Cardiac SurgeryNCT02814851

Evaluation of Cardiac Hemodynamic Modifications During Temporary Left Atrial Appendage Occlusion

A study testing Transesophageal echocardiogram, Thermistor-tipped catheter and Pressure/volume catheter in people with Cardiac Surgery, run by Brugmann University Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Surgery
What is being tested?: Transesophageal echocardiogram, Thermistor-tipped catheter and Pressure/volume catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteBelgium
Study dates: 1 Aug 2016to 28 May 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aortic valve stenosis suitable to surgery
Left Atrium<50 mm in the parasternal long axis view
Sinus rhythm at the time of patient's inclusion and during the procedure

Who cannot join

Hypertrophic cardiomyopathy (diastolic septal thickness > 15mm).
Heart failure with Left Ventricule Ejection Fraction < 45%.
Significant mitral regurgitation/stenosis
Significant aortic regurgitation
History of atrial fibrillation
Presence of prosthetic valves
Complex congenital heart disease

Trial locations and contacts

1 site in 1 country.

Belgium1 site

CHU Brugmann
Brussels, 1020

Other trials in Belgium

About this study

The left atrium appendage (LAA) is a remnant of the original embryonic left atrium formed during the third week of gestation. LAA is believed to function as a decompression chamber during left ventricular systole and other periods when left atrial pressure is elevated. The LAA is also a major endocrine organ and is the main producer of ANP (atrial natriuretic peptide) in the human heart. The ANP concentration is 40 times higher in the LAA walls than in the rest of the atrial wall. A study of patients having undergone the maze procedure and associated LAA removal found a significantly lower ANP secretion and an increase in salt and water retention. Whether this could eventually lead to hypertension or heart failure symptoms is not known.

Removal of the LAA is routinely performed during antiarrhythmic surgical techniques ("MAZE surgery") to reduce the risk of subsequent LAA thrombus. Furthermore, new percutaneous ablation techniques target LAA to reduce further risks of atrial fibrilation recurrences. However, in addition to effects on diastolic atrial function and atrial natriuretic peptide (ANP) secretion, this could potentially reduce stroke volume and cardiac output and may thus promote heart failure. Its removal could be particularly detrimental in patients with existing heart failure and high intraatrial pressure, as it would further promote pulmonary congestion and also reduce their cardiac output.

The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and cardiology wards. Subjects referred for non valvular cardiac surgery will be prospectively included during the first 6 months following the onset of the protocol. Echocardiographic and invasive data will be collected simultaneously.

The goals of the study are:

To evaluate the immediate impact of temporary closure of the LAA using a vascular clamp in the beating heart of human subjects during cardiac surgery. Impact of LAA occlusion will be measured using transesophageal echocardiography and hemodynamic measurement of the cardiac output.
To correlate echocardiographic parameters with in situ hemodynamic data.

A significant role of the LAA in the cardiac hemodynamic including the left ventricle outflow might have different clinical implications and will raise questions about:

Appropriateness of LAA resection in antiarrhythmic surgery
Importance of restoring sinus rhythm in atrial fibrilation patients
Importance to spare LAA from ablation during atrial fibrilation ablation to avoid significant consequences on cardiac function.
Appropriateness of the LAA occluding device in atrial fibrillation patients.

Conditions: Cardiac Surgery
Being tested: Transesophageal echocardiogram, Thermistor-tipped catheter, Pressure/volume catheter, Transthoracic echocardiography
Keywords: Left atrium appendage (LAA) occlusion, Transesophageal echocardiography, Cardiac output hemodynamic measurement, Leycom Pressure/Volume Combination Catheter
Medical subject headings: Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transesophageal echocardiogramDevice
All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann. A transesophageal echocardiogram (TEE) will be performed and the TEE probe will stay continuously during the entire procedure, to allow all necessary measurements.
Thermistor-tipped catheterDevice
All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a thermistor-tipped catheter (model 93A-131-7F, Edwards, Santa Ana, CA) will be inserted into the pulmonary artery to measure right atrial pressure (Pra), pulmonary arterial pressure (Ppa), Ppao and thermodilution cardiac output. Ringer's lactate will be infused to maintain an occluded pulmonary arterial pressure (Ppao) of 8-10 mmHg.
Pressure/volume catheterDevice
All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a pressure/volume catheter (CD Leicom, Zoetermeer, Netherland) will be placed in the left ventricle through a left superior pulmonary vein purse string, in order to measure alternatively LV pressure/volume loops and LA pressure.
Transthoracic echocardiographyDevice
A complete transthoracic echocardiography will be performed the day before the surgical procedure. It will establish the presence of the inclusion and exclusion criteria, as stipulated above. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands).
During the surgical procedure, a transesophageal echocardiogram will be performed, using an Acuson Sequoia system (Siemens AG, Germany).

Study groups in NCT02814851
Study group	Role	What they receive
Non valvular cardiac surgery	Experimental	The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and cardiology wards. Subjects referred for non valvular cardiac surgery will be prospectively included during the first 6 months following the onset of the protocol. Receives: Device: Transesophageal echocardiogram; Device: Thermistor-tipped catheter; Device: Pressure/volume catheter; Device: Transthoracic echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

Left atrium (LA) dP/dt max
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: Baseline (before LAA clamping)
Left atrium dP/dt max
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: 5 minutes after LAA clamping
Left atrium output
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
Measured: Baseline (before LAA clamping)
Left atrium output
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
Measured: 5 minutes after LAA clamping
Left atrium contractility index (dP/dt max)/P
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: Baseline (before LAA clamping)
Left atrium contractility index (dP/dt max)/P
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: 5 minutes after LAA clamping
Left ventricle (LV) dP/dt max
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: Baseline (before LAA clamping)
Left ventricle dP/dt max
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: 5 minutes after LAA clamping
Left ventricle output
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
Measured: Baseline (before LAA clamping)
Left ventricle output
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
Measured: 5 minutes after LAA clamping
LV contractility index (dP/dt max)/P
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. LV contractility will be estimated from the slope of the end-systolic pressure-volume relation.
Measured: Baseline (before LAA clamping)
LV contractility index (dP/dt max)/P
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. LV contractility will be estimated from the slope of the end-systolic pressure-volume relation.
Measured: 5 minutes after LAA clamping
Occluded pulmonary arterial pressure (Ppao)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: Baseline (before LAA clamping)
Occluded pulmonary arterial pressure (Ppao)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Measured: 5 minutes after LAA clamping

Secondary outcomes (14)

Area fractional shortening (AFS) of the left atrium appendage (LAA)
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: AFS 2CME90°= (Amax-Amin)/Amax.
Measured: Baseline (before LAA clamping)
Area fractional shortening (AFS) of the left atrium appendage (LAA)
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: AFS 2CME90°= (Amax-Amin)/Amax.
Measured: 5 minutes after LAA clamping
Ejection volume of the LAA (left atrium appendage)
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: LAA ejection volume= 3,14*D1*D2*TVI PW LAA/4, where D1 and D2 are the diameters of the opening of the LAA at 0° and 90°
Measured: Baseline (before LAA clamping)
Ejection volume of the LAA (left atrium appendage)
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: LAA ejection volume= 3,14*D1*D2*TVI PW LAA/4, where D1 and D2 are the diameters of the opening of the LAA at 0° and 90°
Measured: 5 minutes after LAA clamping
Stroke volume
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: Stroke volume= 3,14D²*Aortic PW TVI /4, where D is the LVOT (left ventricular outflow tract)diameter in A3C.
Measured: Baseline (before LAA clamping)
Stroke volume
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). Computed with the following formula: Stroke volume= 3,14D²*Aortic PW TVI /4, where D is the LVOT (left ventricular outflow tract) diameter in A3C.
Measured: 5 minutes after LAA clamping
Amplitude of the emptying pulse wave of the LAA (left atrium appendage)
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). 2C ME 90° measure
Measured: Baseline (before LAA clamping)
Amplitude of the emptying pulse wave of the LAA (left atrium appendage)
Transesophageal echocardiography data (Acuson Sequoia system - Siemens AG, Germany). 2C ME 90° measure
Measured: 5 minutes after LAA clamping
TVI (Aortic Time-Velocity Integral) of the emptying pulse wave of the LAA (left atrium appendage)
Transgastric or deep transgastric aortic Pulse Wave Doppler. 2C ME 90° measure
Measured: Baseline (before LAA clamping)
TVI (Aortic Time-Velocity Integral) of the emptying pulse wave of the LAA (left atrium appendage)
Transgastric or deep transgastric aortic Pulse Wave Doppler. 2C ME 90° measure
Measured: 5 minutes after LAA clamping
Amplitude of the mitral A wave
Amplitude A wave: measured with DTI (Tissue Doppler ) 4C ME 0° lateral ring
Measured: Baseline (before LAA clamping)
Amplitude of the mitral A wave
Amplitude A wave: measured with DTI (Tissue Doppler ) 4C ME 0° lateral ring
Measured: 5 minutes after LAA clamping
TVI (Aortic Time-Velocity Integral) of the left upper pulmonary vein (LUPV)
Measured by aortic Pulse Wave (PW) Doppler flow
Measured: Baseline (before LAA clamping)
TVI (Aortic Time-Velocity Integral) of the left upper pulmonary vein (LUPV)
Measured by aortic Pulse Wave (PW) Doppler flow
Measured: 5 minutes after LAA clamping

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 201628 May 2018

First posted28 Jun 2016 (estimated)
Study start1 Aug 2016
Primary completion28 May 2018
Study completion28 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02814851
Sponsor's protocol ID: CHUB-LAA-Ligature
Status last verified: Apr 2019
First submitted: 20 Apr 2016
Last updated: 17 Apr 2019
Results posted: No
Data monitoring committee: No

Publications

Pritchett AM, Jacobsen SJ, Mahoney DW, Rodeheffer RJ, Bailey KR, Redfield MM. Left atrial volume as an index of left atrial size: a population-based study. J Am Coll Cardiol. 2003 Mar 19;41(6):1036-43. doi: 10.1016/s0735-1097(02)02981-9.
PubMed 12651054
Moller JE, Hillis GS, Oh JK, Seward JB, Reeder GS, Wright RS, Park SW, Bailey KR, Pellikka PA. Left atrial volume: a powerful predictor of survival after acute myocardial infarction. Circulation. 2003 May 6;107(17):2207-12. doi: 10.1161/01.CIR.0000066318.21784.43. Epub 2003 Apr 14.
PubMed 12695291
Tsang TS, Barnes ME, Gersh BJ, Takemoto Y, Rosales AG, Bailey KR, Seward JB. Prediction of risk for first age-related cardiovascular events in an elderly population: the incremental value of echocardiography. J Am Coll Cardiol. 2003 Oct 1;42(7):1199-205. doi: 10.1016/s0735-1097(03)00943-4.
PubMed 14522480
Osranek M, Fatema K, Qaddoura F, Al-Saileek A, Barnes ME, Bailey KR, Gersh BJ, Tsang TS, Zehr KJ, Seward JB. Left atrial volume predicts the risk of atrial fibrillation after cardiac surgery: a prospective study. J Am Coll Cardiol. 2006 Aug 15;48(4):779-86. doi: 10.1016/j.jacc.2006.03.054. Epub 2006 Jul 25.
PubMed 16904549
Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Left atrial volume as a morphophysiologic expression of left ventricular diastolic dysfunction and relation to cardiovascular risk burden. Am J Cardiol. 2002 Dec 15;90(12):1284-9. doi: 10.1016/s0002-9149(02)02864-3.
PubMed 12480035
Stollberger C, Schneider B, Finsterer J. Elimination of the left atrial appendage to prevent stroke or embolism? Anatomic, physiologic, and pathophysiologic considerations. Chest. 2003 Dec;124(6):2356-62. doi: 10.1378/chest.124.6.2356.
PubMed 14665520
Al-Saady NM, Obel OA, Camm AJ. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999 Nov;82(5):547-54. doi: 10.1136/hrt.82.5.547.
PubMed 10525506
Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9. doi: 10.1161/01.cir.0000015698.54752.6d.
PubMed 11997272
Akosah KO, Funai JT, Porter TR, Jesse RL, Mohanty PK. Left atrial appendage contractile function in atrial fibrillation. Influence of heart rate and cardioversion to sinus rhythm. Chest. 1995 Mar;107(3):690-6. doi: 10.1378/chest.107.3.690.
PubMed 7874938
Kamohara K, Popovic ZB, Daimon M, Martin M, Ootaki Y, Akiyama M, Zahr F, Cingoz F, Ootaki C, Kopcak MW Jr, Dessoffy R, Liu J, Thomas JD, Gillinov AM, Fukamachi K. Impact of left atrial appendage exclusion on left atrial function. J Thorac Cardiovasc Surg. 2007 Jan;133(1):174-81. doi: 10.1016/j.jtcvs.2006.08.057.
PubMed 17198808
Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
PubMed 16376782

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Cardiac Hemodynamic Modifications During Temporary Left Atrial Appendage Occlusion
ClinicalTrials.gov ID: NCT02814851
Acronym / sponsor ID: CHUB-LAA-Ligature
Conditions: Cardiac Surgery
Keywords: Left atrium appendage (LAA) occlusion, Transesophageal echocardiography, Cardiac output hemodynamic measurement, Leycom Pressure/Volume Combination Catheter
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Brugmann University HospitalUniversity, hospital or other
Study start: 1 Aug 2016 (actual)
Primary completion: 28 May 2018 (actual)
Study completion: 28 May 2018 (actual)
First posted: 28 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goals of the study are:

To evaluate the immediate impact of temporary closure of the LAA using a vascular clamp in the beating heart of human subjects during cardiac surgery. Impact of LAA occlusion will be measured using transesophageal echocardiography and hemodynamic measurement of the cardiac output.
To correlate echocardiographic parameters with in situ hemodynamic data.

A significant role of the LAA in the cardiac hemodynamic including the left ventricle outflow might have different clinical implications and will raise questions about:

Appropriateness of LAA resection in antiarrhythmic surgery
Importance of restoring sinus rhythm in atrial fibrilation patients
Importance to spare LAA from ablation during atrial fibrilation ablation to avoid significant consequences on cardiac function.
Appropriateness of the LAA occluding device in atrial fibrillation patients.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Non valvular cardiac surgery	Experimental	Device: Transesophageal echocardiogram, Device: Thermistor-tipped catheter, Device: Pressure/volume catheter, Device: Transthoracic echocardiographyThe study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and cardiology wards. Subjects referred for non valvular cardiac surgery will be prospectively included during the first 6 months following the onset of the protocol.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aortic valve stenosis suitable to surgery
Left Atrium<50 mm in the parasternal long axis view
Sinus rhythm at the time of patient's inclusion and during the procedure

Key exclusion criteria (7 listed)

Hypertrophic cardiomyopathy (diastolic septal thickness > 15mm).
Heart failure with Left Ventricule Ejection Fraction < 45%.
Significant mitral regurgitation/stenosis
Significant aortic regurgitation
History of atrial fibrillation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transesophageal echocardiogramAll patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann. A transesophageal echocardiogram (TEE) will be performed and the TEE probe will stay continuously during the entire procedure, to allow all necessary measurements.	Device	Non valvular cardiac surgery
Thermistor-tipped catheterAll patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a thermistor-tipped catheter (model 93A-131-7F, Edwards, Santa Ana, CA) will be inserted into the pulmonary artery to measure right atrial pressure (Pra), pulmonary arterial pressure (Ppa), Ppao and thermodilution cardiac output. Ringer's lactate will be infused to maintain an occluded pulmonary arterial pressure (Ppao) of 8-10 mmHg.	Device	Non valvular cardiac surgery
Pressure/volume catheterAll patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a pressure/volume catheter (CD Leicom, Zoetermeer, Netherland) will be placed in the left ventricle through a left superior pulmonary vein purse string, in order to measure alternatively LV pressure/volume loops and LA pressure.	Device	Non valvular cardiac surgery
Transthoracic echocardiographyA complete transthoracic echocardiography will be performed the day before the surgical procedure. It will establish the presence of the inclusion and exclusion criteria, as stipulated above. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands). During the surgical procedure, a transesophageal echocardiogram will be performed, using an Acuson Sequoia system (Siemens AG, Germany).	Device	Non valvular cardiac surgery

Primary outcome

Left atrium (LA) dP/dt max
Time frame: Baseline (before LAA clamping)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Left atrium dP/dt max
Time frame: 5 minutes after LAA clamping
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Left atrium output
Time frame: Baseline (before LAA clamping)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
Left atrium output
Time frame: 5 minutes after LAA clamping
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
Left atrium contractility index (dP/dt max)/P
Time frame: Baseline (before LAA clamping)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Left atrium contractility index (dP/dt max)/P
Time frame: 5 minutes after LAA clamping
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Left ventricle (LV) dP/dt max
Time frame: Baseline (before LAA clamping)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Left ventricle dP/dt max
Time frame: 5 minutes after LAA clamping
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Left ventricle output
Time frame: Baseline (before LAA clamping)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
Left ventricle output
Time frame: 5 minutes after LAA clamping
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. The cardiac output will be measured by thermodilution (REF-1 computer, Edwards, Irvine, CA).
LV contractility index (dP/dt max)/P
Time frame: Baseline (before LAA clamping)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. LV contractility will be estimated from the slope of the end-systolic pressure-volume relation.
LV contractility index (dP/dt max)/P
Time frame: 5 minutes after LAA clamping
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis. LV contractility will be estimated from the slope of the end-systolic pressure-volume relation.
Occluded pulmonary arterial pressure (Ppao)
Time frame: Baseline (before LAA clamping)
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.
Occluded pulmonary arterial pressure (Ppao)
Time frame: 5 minutes after LAA clamping
Fluid-filled catheter-derived pressures will be zero-referenced at mid-chest level and processed using disposable transducers (Baxter-Bentley, Uden, the Netherlands) and a Sirecust 404 monitoring system (Siemens, Erlangen, Germany). Micromanometer-derived pressures and conductance catheter data will be processed using a Leicom INCA intracardiac monitor (CD Leycom, Zoetermeer, Netherlands). All pressures and volume signals will be digitalized at 200 Hz and stored in a PC for off-line analysis.

14 secondary outcomes

Area fractional shortening (AFS) of the left atrium appendage (LAA)
Time frame: Baseline (before LAA clamping)
Area fractional shortening (AFS) of the left atrium appendage (LAA)
Time frame: 5 minutes after LAA clamping
Ejection volume of the LAA (left atrium appendage)
Time frame: Baseline (before LAA clamping)
Ejection volume of the LAA (left atrium appendage)
Time frame: 5 minutes after LAA clamping
Stroke volume
Time frame: Baseline (before LAA clamping)
Stroke volume
Time frame: 5 minutes after LAA clamping
Amplitude of the emptying pulse wave of the LAA (left atrium appendage)
Time frame: Baseline (before LAA clamping)
Amplitude of the emptying pulse wave of the LAA (left atrium appendage)
Time frame: 5 minutes after LAA clamping
TVI (Aortic Time-Velocity Integral) of the emptying pulse wave of the LAA (left atrium appendage)
Time frame: Baseline (before LAA clamping)
TVI (Aortic Time-Velocity Integral) of the emptying pulse wave of the LAA (left atrium appendage)
Time frame: 5 minutes after LAA clamping
Amplitude of the mitral A wave
Time frame: Baseline (before LAA clamping)
Amplitude of the mitral A wave
Time frame: 5 minutes after LAA clamping
TVI (Aortic Time-Velocity Integral) of the left upper pulmonary vein (LUPV)
Time frame: Baseline (before LAA clamping)
TVI (Aortic Time-Velocity Integral) of the left upper pulmonary vein (LUPV)
Time frame: 5 minutes after LAA clamping

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
Background: PubMed 12651054Pritchett AM, Jacobsen SJ, Mahoney DW, Rodeheffer RJ, Bailey KR, Redfield MM. Left atrial volume as an index of left atrial size: a population-based study. J Am Coll Cardiol. 2003 Mar 19;41(6):1036-43. doi: 10.1016/s0735-1097(02)02981-9.
Background: PubMed 12695291Moller JE, Hillis GS, Oh JK, Seward JB, Reeder GS, Wright RS, Park SW, Bailey KR, Pellikka PA. Left atrial volume: a powerful predictor of survival after acute myocardial infarction. Circulation. 2003 May 6;107(17):2207-12. doi: 10.1161/01.CIR.0000066318.21784.43. Epub 2003 Apr 14.
Background: PubMed 14522480Tsang TS, Barnes ME, Gersh BJ, Takemoto Y, Rosales AG, Bailey KR, Seward JB. Prediction of risk for first age-related cardiovascular events in an elderly population: the incremental value of echocardiography. J Am Coll Cardiol. 2003 Oct 1;42(7):1199-205. doi: 10.1016/s0735-1097(03)00943-4.
Background: PubMed 16904549Osranek M, Fatema K, Qaddoura F, Al-Saileek A, Barnes ME, Bailey KR, Gersh BJ, Tsang TS, Zehr KJ, Seward JB. Left atrial volume predicts the risk of atrial fibrillation after cardiac surgery: a prospective study. J Am Coll Cardiol. 2006 Aug 15;48(4):779-86. doi: 10.1016/j.jacc.2006.03.054. Epub 2006 Jul 25.
Background: PubMed 12480035Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Left atrial volume as a morphophysiologic expression of left ventricular diastolic dysfunction and relation to cardiovascular risk burden. Am J Cardiol. 2002 Dec 15;90(12):1284-9. doi: 10.1016/s0002-9149(02)02864-3.
Background: PubMed 14665520Stollberger C, Schneider B, Finsterer J. Elimination of the left atrial appendage to prevent stroke or embolism? Anatomic, physiologic, and pathophysiologic considerations. Chest. 2003 Dec;124(6):2356-62. doi: 10.1378/chest.124.6.2356.
Background: PubMed 10525506Al-Saady NM, Obel OA, Camm AJ. Left atrial appendage: structure, function, and role in thromboembolism. Heart. 1999 Nov;82(5):547-54. doi: 10.1136/hrt.82.5.547.
Background: PubMed 11997272Sievert H, Lesh MD, Trepels T, Omran H, Bartorelli A, Della Bella P, Nakai T, Reisman M, DiMario C, Block P, Kramer P, Fleschenberg D, Krumsdorf U, Scherer D. Percutaneous left atrial appendage transcatheter occlusion to prevent stroke in high-risk patients with atrial fibrillation: early clinical experience. Circulation. 2002 Apr 23;105(16):1887-9. doi: 10.1161/01.cir.0000015698.54752.6d.
Background: PubMed 7874938Akosah KO, Funai JT, Porter TR, Jesse RL, Mohanty PK. Left atrial appendage contractile function in atrial fibrillation. Influence of heart rate and cardioversion to sinus rhythm. Chest. 1995 Mar;107(3):690-6. doi: 10.1378/chest.107.3.690.
Background: PubMed 17198808Kamohara K, Popovic ZB, Daimon M, Martin M, Ootaki Y, Akiyama M, Zahr F, Cingoz F, Ootaki C, Kopcak MW Jr, Dessoffy R, Liu J, Thomas JD, Gillinov AM, Fukamachi K. Impact of left atrial appendage exclusion on left atrial function. J Thorac Cardiovasc Surg. 2007 Jan;133(1):174-81. doi: 10.1016/j.jtcvs.2006.08.057.
Background: PubMed 16376782Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pierre Wauthy, MD principal investigator

CHU Brugmann

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transesophageal echocardiogram, Thermistor-tipped catheter and Pressure/volume catheter in people with Cardiac Surgery, run by Brugmann University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left atrium (LA) dP/dt max (time frame: Baseline (before LAA clamping)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02814851, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.