Heart Failure, SystolicNCT01129635
Optimal Coronary Sinus Lead Implantation Using Intracardiac Impedography and Magnetic Resonance Imaging
A study testing Cardiac Resynchronization Therapy (CRT) implantation in people with Heart Failure, Systolic and Left Bundle Branch Block, run by Emory University at 1 site in United States.
Trial summary
Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Systolic, Left Bundle Branch Block
- What is being tested?
- Cardiac Resynchronization Therapy (CRT) implantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with NYHA class III or IV heart failure
- LVEF ≤ 30%
- QRS duration ≥ 120 ms
Who cannot join
- Not a candidate for CRT implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-Time Intracardiac Impedograms of Left Ventricular Leads to Locate Sites of Latest Mechanical Delay in Cardiac Resynchronization Therapy
Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.
Read the detailed description
This is a clinical trial using intracardiac impedance signals (impedograms) to assess regional dyssynchrony at various sites of left ventricular (LV) lead placement in humans undergoing CRT device implantation. This study will test the following hypotheses during the funding period:
- LV lead impedograms as an implant tool to place leads at sites of latest mechanical delay are feasible and correlate with other means of assessing dyssynchrony.
- LV lead impedograms vary significantly depending on LV lead location.
- There are several characteristics of LV lead impedograms that correlate with mechanical phenomena of the heart.
- Conditions
- Heart Failure, Systolic, Left Bundle Branch Block
- Being tested
- Cardiac Resynchronization Therapy (CRT) implantation
- Keywords
- Heart failure, Cardiac resynchronization therapy, Regional left ventricular dyssynchrony, CRT
- Medical subject headings
- Heart Failure, Systolic, Bundle-Branch Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization Therapy (CRT) implantationProcedure or surgery
The impedance measurement is performed during device implantation following CMR. After the RV and LV leads are inserted, secured and tested, they will be connected to the impedance monitor. Impedance recording of at least ten beats will be acquired and stored for future analysis. Each recording will be tagged with the anatomical location of the LV lead. Subsequently, the LV lead will be moved to a different location and the same procedure will be repeated until accessible coronary sinus sites are exhausted. The ultimate LV lead location is determined by the implanting electrophysiologist and is not constrained by the study protocol. Finally, the LV lead will be tested again and the rest of the implantation procedure will proceed as routine.
Arm: CRT Candidate
| Study group | Role | What they receive |
|---|---|---|
| CRT Candidate | Experimental | Patients with NYHA Class III or IV heart failure; EF ≤ 30% and QRS duration ≥ 120 ms, who are scheduled for CRT surgery.
Intervention: Cardiac Resynchronization Therapy (CRT) implantation Receives: Procedure: Cardiac Resynchronization Therapy (CRT) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map.
Parameter will be recorded for at least 10 consecutive heartbeats during sinus and RV paced rhythm
Ts = The average time from the sensed RV IEGM to the peak of the LV impedance curve
Measured: Acute intraoperative measurement
Secondary outcomes (1)
Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map.
Ts: The average time from the sensed RV IEGM to the peak of the LV impedance curve.
Tp: The average time from the paced RV IEGM to the peak of the LV impedance curve.
Td: The difference between Ts and Tp (Tp - Ts).
Measured: Acute intraoperative measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael S. Lloyd, Emory University
- Investigators
- Michael S. Lloyd, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129635
- Sponsor's protocol ID
- IRB00036655
- Other IDs
- ACTSI-EP-001
- Status last verified
- Jan 2015
- First submitted
- 5 May 2010
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
PubMed 12063368Jessup M. MADIT-CRT--breathtaking or time to catch our breath? N Engl J Med. 2009 Oct 1;361(14):1394-6. doi: 10.1056/NEJMe0907335. Epub 2009 Sep 1. No abstract available.
PubMed 19723700Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
PubMed 19723701Couri DM, Mankad S. Cardiac resynchronization therapy. Curr Treat Options Cardiovasc Med. 2008 Dec;10(6):538-48. doi: 10.1007/s11936-008-0046-5.
PubMed 19026184Lloyd MS, Heeke S, Lerakis S, Langberg JJ. Reverse polarity pacing: the hemodynamic benefit of anodal currents at lead tips for cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2007 Nov;18(11):1167-71. doi: 10.1111/j.1540-8167.2007.00943.x.
PubMed 17764446Mounsey JP, Knisley SB. Anodal capture, cathodal capture, and left ventricular cardiac excitation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):650-2. doi: 10.1111/j.1540-8167.2008.01418.x. Epub 2009 Jan 9. No abstract available.
PubMed 19175447Theis C, Bavikati VV, Langberg JJ, Lloyd MS. The relationship of bipolar left ventricular pacing stimulus intensity to cardiac depolarization and repolarization in humans with cardiac resynchronization devices. J Cardiovasc Electrophysiol. 2009 Jun;20(6):645-9. doi: 10.1111/j.1540-8167.2008.01378.x. Epub 2009 Dec 15.
PubMed 19207760Becker M, Franke A, Breithardt OA, Ocklenburg C, Kaminski T, Kramann R, Knackstedt C, Stellbrink C, Hanrath P, Schauerte P, Hoffmann R. Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study. Heart. 2007 Oct;93(10):1197-203. doi: 10.1136/hrt.2006.095612. Epub 2007 Feb 19.
PubMed 17309913Becker M, Kramann R, Franke A, Breithardt OA, Heussen N, Knackstedt C, Stellbrink C, Schauerte P, Kelm M, Hoffmann R. Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography. Eur Heart J. 2007 May;28(10):1211-20. doi: 10.1093/eurheartj/ehm034. Epub 2007 Apr 10.
PubMed 17426079Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
PubMed 18458170Koos R, Neizel M, Schummers G, Krombach GA, Stanzel S, Gunther RW, Kelm M, Kuhl HP. Feasibility and initial experience of assessment of mechanical dyssynchrony using cardiovascular magnetic resonance and semi-automatic border detection. J Cardiovasc Magn Reson. 2008 Nov 4;10(1):49. doi: 10.1186/1532-429X-10-49.
PubMed 18983646Tsao J, Kozerke S, Boesiger P, Pruessmann KP. Optimizing spatiotemporal sampling for k-t BLAST and k-t SENSE: application to high-resolution real-time cardiac steady-state free precession. Magn Reson Med. 2005 Jun;53(6):1372-82. doi: 10.1002/mrm.20483.
PubMed 15906282RUSHMER RF, CRYSTAL DK, WAGNER C, ELLIS RM. Intracardiac impedance plethysmography. Am J Physiol. 1953 Jul;174(1):171-4. doi: 10.1152/ajplegacy.1953.174.1.171. No abstract available.
PubMed 13065515Salo RW, Wallner TG, Pederson BD. Measurement of ventricular volume by intracardiac impedance: theoretical and empirical approaches. IEEE Trans Biomed Eng. 1986 Feb;33(2):189-95. doi: 10.1109/TBME.1986.325890. No abstract available.
PubMed 3957369Kaye G, Edgar D, Mudawi T, Lippert M, Czygan G. Can transventricular intracardiac impedance measurement discriminate haemodynamically unstable ventricular arrhythmias in human? Europace. 2007 Feb;9(2):122-6. doi: 10.1093/europace/eul150.
PubMed 17272334
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Intracardiac Impedograms of Left Ventricular Leads to Locate Sites of Latest Mechanical Delay in Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT01129635
- Acronym / sponsor ID
- IRB00036655
- Conditions
- Heart Failure, Systolic, Left Bundle Branch Block
- Keywords
- Heart failure, Cardiac resynchronization therapy, Regional left ventricular dyssynchrony, CRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 May 2010 (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.
Despite the dramatic effect of cardiac resynchronization therapy (CRT) on survival and morbidity in people with congestive heart failure, 50-70% of eligible patients do not respond to this intervention. There is retrospective evidence that placement of the left ventricular (LV) lead at the region of latest mechanical delay markedly improves response to CRT. However, there is no feasible way to gauge dyssynchrony at LV lead sites during CRT implantation. Impedance recordings from pacing lead tips allow for real-time assessment of mechanical motion and may represent a useful intraoperative tool to guide optimum placement of the LV lead during CRT implantation. This pilot trial will assess the use of intraoperative impedograms in humans to measure regional dyssynchrony at potential LV lead locations during CRT implantation.
Detailed description
This is a clinical trial using intracardiac impedance signals (impedograms) to assess regional dyssynchrony at various sites of left ventricular (LV) lead placement in humans undergoing CRT device implantation. This study will test the following hypotheses during the funding period:
- LV lead impedograms as an implant tool to place leads at sites of latest mechanical delay are feasible and correlate with other means of assessing dyssynchrony.
- LV lead impedograms vary significantly depending on LV lead location.
- There are several characteristics of LV lead impedograms that correlate with mechanical phenomena of the heart.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT Candidate | Experimental | Procedure: Cardiac Resynchronization Therapy (CRT) implantationPatients with NYHA Class III or IV heart failure; EF ≤ 30% and QRS duration ≥ 120 ms, who are scheduled for CRT surgery. Intervention: Cardiac Resynchronization Therapy (CRT) implantation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with NYHA class III or IV heart failure
- LVEF ≤ 30%
- QRS duration ≥ 120 ms
Key exclusion criteria (1 listed)
- Not a candidate for CRT implantation
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 |
|---|---|---|
| Cardiac Resynchronization Therapy (CRT) implantationThe impedance measurement is performed during device implantation following CMR. After the RV and LV leads are inserted, secured and tested, they will be connected to the impedance monitor. Impedance recording of at least ten beats will be acquired and stored for future analysis. Each recording will be tagged with the anatomical location of the LV lead. Subsequently, the LV lead will be moved to a different location and the same procedure will be repeated until accessible coronary sinus sites are exhausted. The ultimate LV lead location is determined by the implanting electrophysiologist and is not constrained by the study protocol. Finally, the LV lead will be tested again and the rest of the implantation procedure will proceed as routine. Arm: CRT Candidate | Procedure or surgery | CRT Candidate |
Primary outcome
Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map.
Time frame: Acute intraoperative measurement
Parameter will be recorded for at least 10 consecutive heartbeats during sinus and RV paced rhythm Ts = The average time from the sensed RV IEGM to the peak of the LV impedance curve
1 secondary outcome
Differential correlation of Ts, Tp, and Td (see description) to the CMR dyssynchrony map.
Time frame: Acute intraoperative measurement
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 21 Jan 2015.
- Background: PubMed 12063368Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
- Background: PubMed 19723700Jessup M. MADIT-CRT--breathtaking or time to catch our breath? N Engl J Med. 2009 Oct 1;361(14):1394-6. doi: 10.1056/NEJMe0907335. Epub 2009 Sep 1. No abstract available.
- Background: PubMed 19723701Moss AJ, Hall WJ, Cannom DS, Klein H, Brown MW, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Higgins SL, Pfeffer MA, Solomon SD, Wilber D, Zareba W; MADIT-CRT Trial Investigators. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009 Oct 1;361(14):1329-38. doi: 10.1056/NEJMoa0906431. Epub 2009 Sep 1.
- Background: PubMed 19026184Couri DM, Mankad S. Cardiac resynchronization therapy. Curr Treat Options Cardiovasc Med. 2008 Dec;10(6):538-48. doi: 10.1007/s11936-008-0046-5.
- Background: PubMed 17764446Lloyd MS, Heeke S, Lerakis S, Langberg JJ. Reverse polarity pacing: the hemodynamic benefit of anodal currents at lead tips for cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2007 Nov;18(11):1167-71. doi: 10.1111/j.1540-8167.2007.00943.x.
- Background: PubMed 19175447Mounsey JP, Knisley SB. Anodal capture, cathodal capture, and left ventricular cardiac excitation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):650-2. doi: 10.1111/j.1540-8167.2008.01418.x. Epub 2009 Jan 9. No abstract available.
- Background: PubMed 19207760Theis C, Bavikati VV, Langberg JJ, Lloyd MS. The relationship of bipolar left ventricular pacing stimulus intensity to cardiac depolarization and repolarization in humans with cardiac resynchronization devices. J Cardiovasc Electrophysiol. 2009 Jun;20(6):645-9. doi: 10.1111/j.1540-8167.2008.01378.x. Epub 2009 Dec 15.
- Background: PubMed 17309913Becker M, Franke A, Breithardt OA, Ocklenburg C, Kaminski T, Kramann R, Knackstedt C, Stellbrink C, Hanrath P, Schauerte P, Hoffmann R. Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study. Heart. 2007 Oct;93(10):1197-203. doi: 10.1136/hrt.2006.095612. Epub 2007 Feb 19.
- Background: PubMed 17426079Becker M, Kramann R, Franke A, Breithardt OA, Heussen N, Knackstedt C, Stellbrink C, Schauerte P, Kelm M, Hoffmann R. Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography. Eur Heart J. 2007 May;28(10):1211-20. doi: 10.1093/eurheartj/ehm034. Epub 2007 Apr 10.
- Background: PubMed 18458170Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
- Background: PubMed 18983646Koos R, Neizel M, Schummers G, Krombach GA, Stanzel S, Gunther RW, Kelm M, Kuhl HP. Feasibility and initial experience of assessment of mechanical dyssynchrony using cardiovascular magnetic resonance and semi-automatic border detection. J Cardiovasc Magn Reson. 2008 Nov 4;10(1):49. doi: 10.1186/1532-429X-10-49.
- Background: PubMed 15906282Tsao J, Kozerke S, Boesiger P, Pruessmann KP. Optimizing spatiotemporal sampling for k-t BLAST and k-t SENSE: application to high-resolution real-time cardiac steady-state free precession. Magn Reson Med. 2005 Jun;53(6):1372-82. doi: 10.1002/mrm.20483.
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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.
Michael S. Lloyd, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Resynchronization Therapy (CRT) implantation in people with Heart Failure, Systolic and Left Bundle Branch Block, run by Emory University at 1 site in United States.
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 1 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 21 Jan 2015. 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 United States. 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?
Anatomic correlation between largest Ts (see description) and site of longest delay among probed locations in the CMR dyssynchrony map. (time frame: Acute intraoperative measurement). 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 NCT01129635, which also lists 18 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 21 Jan 2015.