Atrial FibrillationINSIDEPVsNCT03372798
INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation
An observational study of Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall thickness and about its acute changes during energy delivery for ablation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ICE/IVUS imaging during atrial fibrillation ablation
- Type of treatment
- Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective atrial fibrillation (AF) ablation in view of a history of symptomatic and drug-refractory paroxysmal AF.
Who may be able to join
- Males older than 40 years or females older than 40 and sterile or in post-menopausal age;
- willing and able to give informed consent for participation in the study;
- history of symptomatic and drug-refractory paroxysmal atrial fibrillation (AF);
- planned AF ablation on a clinical basis.
Who cannot join
- age less than 40 years and more than 80 years;
- pregnancy, trying for a baby or breast feeding;
- any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study;
- documented allergy to iodinated contrast medium;
- renal insufficiency (eGFR<30);
- weight exceeding the maximum load of the scanner (250kg).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INtra-procedural ultraSound Imaging for DEtermination of Atrial Wall Thickness and Acute Tissue Changes During Isolation of the Pulmonary Veins
One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall thickness and about its acute changes during energy delivery for ablation. This makes difficult to predict the achievement of transmural lesions, to identify the possible causes of ablation failure and also to avoid the occurrence of perforation and/or other collateral damage.
Computed tomography (CT) is a reliable technique for measurement of the LA wall thickness but it cannot be used during the ablation procedure and its extensive use is limited by the need of ionizing radiation. Preliminary data from animal studies support the accuracy of real-time ultrasound imaging modalities such as intracardiac echocardiography (ICE) or Intravascular Ultrasound (IVUS) imaging for measurement of LA wall thickness and monitoring of its acute changes related to catheter ablation.
The pilot study INSIDE PVs has been primarily designed to evaluate the feasibility and accuracy of intravascular imaging techniques for real-time imaging of the LA wall thickness during AF ablation.
Read the detailed description
Patients scheduled for their first pulmonary vein (PV) isolation ablation for symptomatic, drug-refractory paroxysmal atrial fibrillation (AF), will be considered for inclusion in the study.
Potential subjects will initially be approached some weeks before their ablation procedure, in order to give the patients enough time to consider the information, to ask questions to the Investigator, their general practitioner (GP) or other independent parties to decide whether they wish to participate in the study or not.
For those interested in participation, a baseline assessment will be arranged to coincide with their standard pre-admission visit, for informed consent, screening and eligibility assessment. Moreover, a pre-operative imaging assessment with a cardiac computed tomography (CT) scan will be performed to define the left atrial (LA) and PV anatomy and to measure the baseline LA wall thickness and PVs ostial diameters.
All AF ablation procedures will be performed in a standard fashion by using radiofrequency (RF) energy, cryo-balloon or laser balloon ablation under general anaesthesia and with continuous oesophageal temperature monitoring. Ultrasound imaging by IVUS (Visions PV .018, 20 MHz digital probe, Volcano Corp) or ICE (Ultra ICE (9 MHz rotational transducer, Boston Scientific) will be performed at sites corresponding with the PV/LA junction at the beginning and the end of the procedure in order to measure acute changes in LA wall thickness and PV ostial diameters.
The cardiac CT will be repeated within 24 hours post-procedure. After the procedure, a pre-discharge review and a telephone follow-up at 1 week will be performed to identify any early and late complications related to the procedure.
A total of 14 patients will finally be enrolled in the study. The end of the study for each patient will be the date of the telephone follow-up 1 week after the procedure.
For each patient the pre-procedural and post-procedural CT measurements of LA wall thickness and PVs ostial diameters will be compared with the corresponding IVUS or ICE measurements.
- Conditions
- Atrial Fibrillation
- Being tested
- ICE/IVUS imaging during atrial fibrillation ablation
- Keywords
- catheter ablation, intraprocedural left atrial wall thickness imaging
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE/IVUS imaging during atrial fibrillation ablationProcedure or surgery
Intravascular ultrasound imaging of the left atrial wall thickness with ICE/IVUS during atrial fibrillation ablation
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames
Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = [(vessel area - lumen area)/vessel area] x 100
Measured: Day 1
Measurement of LA Wall Thickness on CT Scans
Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = [(vessel area - lumen area)/vessel area] x 100
Measured: 1 day
Secondary outcomes (2)
Mean Time Required for ICE/IVUS for Real Time Imaging of the Left Atrial (LA) Wall Thickness During AF Ablation
Mean time required to image the left atrium for measurement of left atrial wall thickness with intracardiac echo (ICE) or with intravascular ultrasound (IVUS)
Measured: Day 1
Number of ICE/IVUS Cases of Good Quality
Number of intracardiac echo (ICE) cases and number of intravascular ultrasound (IVUS) cases of good quality, allowing a precise measurement of the left atrial (LA) wall thickness The imaging quality of each PV cross-section was defined as good quality if the vessel contour was visible in all 4 quadrants.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study startNov 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust
- Investigators
- Tim Betts, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372798
- Sponsor's protocol ID
- 12163-SPON
- Acronym
- INSIDEPVs
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2017
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kowalski M, Grimes MM, Perez FJ, Kenigsberg DN, Koneru J, Kasirajan V, Wood MA, Ellenbogen KA. Histopathologic characterization of chronic radiofrequency ablation lesions for pulmonary vein isolation. J Am Coll Cardiol. 2012 Mar 6;59(10):930-8. doi: 10.1016/j.jacc.2011.09.076.
PubMed 22381429Schwartzman D, Ren JF, Devine WA, Callans DJ. Cardiac swelling associated with linear radiofrequency ablation in the atrium. J Interv Card Electrophysiol. 2001 Jun;5(2):159-66. doi: 10.1023/a:1011477408021.
PubMed 11342752Weerasooriya R, Jais P, Sanders P, Scavee C, Hsu LF, Hocini M, Clementy J, Haissaguerre M. Images in cardiovascular medicine. Early appearance of an edematous tissue reaction during left atrial linear ablation using intracardiac echo imaging. Circulation. 2003 Sep 16;108(11):e80. doi: 10.1161/01.CIR.0000083530.08597.B5. No abstract available.
PubMed 12975247Khairy P, Dubuc M. Transcatheter cryoablation part I: preclinical experience. Pacing Clin Electrophysiol. 2008 Jan;31(1):112-20. doi: 10.1111/j.1540-8159.2007.00934.x. No abstract available.
PubMed 18181919Gage AA, Baust J. Mechanisms of tissue injury in cryosurgery. Cryobiology. 1998 Nov;37(3):171-86. doi: 10.1006/cryo.1998.2115.
PubMed 9787063Khairy P, Chauvet P, Lehmann J, Lambert J, Macle L, Tanguay JF, Sirois MG, Santoianni D, Dubuc M. Lower incidence of thrombus formation with cryoenergy versus radiofrequency catheter ablation. Circulation. 2003 Apr 22;107(15):2045-50. doi: 10.1161/01.CIR.0000058706.82623.A1. Epub 2003 Mar 31.
PubMed 12668527Reddy VY, Neuzil P, Themistoclakis S, Danik SB, Bonso A, Rossillo A, Raviele A, Schweikert R, Ernst S, Kuck KH, Natale A. Visually-guided balloon catheter ablation of atrial fibrillation: experimental feasibility and first-in-human multicenter clinical outcome. Circulation. 2009 Jul 7;120(1):12-20. doi: 10.1161/CIRCULATIONAHA.108.840587. Epub 2009 Jun 22.
PubMed 19546385Hall B, Jeevanantham V, Simon R, Filippone J, Vorobiof G, Daubert J. Variation in left atrial transmural wall thickness at sites commonly targeted for ablation of atrial fibrillation. J Interv Card Electrophysiol. 2006 Nov;17(2):127-32. doi: 10.1007/s10840-006-9052-2. Epub 2007 Jan 17.
PubMed 17226084Okada T, Yamada T, Murakami Y, Yoshida N, Ninomiya Y, Shimizu T, Toyama J, Yoshida Y, Ito T, Tsuboi N, Kondo T, Inden Y, Hirai M, Murohara T. Prevalence and severity of left atrial edema detected by electron beam tomography early after pulmonary vein ablation. J Am Coll Cardiol. 2007 Apr 3;49(13):1436-42. doi: 10.1016/j.jacc.2006.10.076. Epub 2007 Mar 21.
PubMed 17397672Granier M, Winum PF, Granier M, Liaud P, Cayla G, Messner P, Pasquie JL, Schuster I. Real-time atrial wall imaging during radiofrequency ablation in a porcine model. Heart Rhythm. 2015 Aug;12(8):1827-35. doi: 10.1016/j.hrthm.2015.04.012. Epub 2015 Apr 8.
PubMed 25863159Ren JF, Callans DJ, Schwartzman D, Michele JJ, Marchlinski FE. Changes in local wall thickness correlate with pathologic lesion size following radiofrequency catheter ablation: an intracardiac echocardiographic imaging study. Echocardiography. 2001 Aug;18(6):503-7. doi: 10.1046/j.1540-8175.2001.00503.x.
PubMed 11567596
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtra-procedural ultraSound Imaging for DEtermination of Atrial Wall Thickness and Acute Tissue Changes During Isolation of the Pulmonary Veins
- ClinicalTrials.gov ID
- NCT03372798
- Acronym / sponsor ID
- INSIDEPVs / 12163-SPON
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation, intraprocedural left atrial wall thickness imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall thickness and about its acute changes during energy delivery for ablation. This makes difficult to predict the achievement of transmural lesions, to identify the possible causes of ablation failure and also to avoid the occurrence of perforation and/or other collateral damage.
Computed tomography (CT) is a reliable technique for measurement of the LA wall thickness but it cannot be used during the ablation procedure and its extensive use is limited by the need of ionizing radiation. Preliminary data from animal studies support the accuracy of real-time ultrasound imaging modalities such as intracardiac echocardiography (ICE) or Intravascular Ultrasound (IVUS) imaging for measurement of LA wall thickness and monitoring of its acute changes related to catheter ablation.
The pilot study INSIDE PVs has been primarily designed to evaluate the feasibility and accuracy of intravascular imaging techniques for real-time imaging of the LA wall thickness during AF ablation.
Detailed description
Patients scheduled for their first pulmonary vein (PV) isolation ablation for symptomatic, drug-refractory paroxysmal atrial fibrillation (AF), will be considered for inclusion in the study.
Potential subjects will initially be approached some weeks before their ablation procedure, in order to give the patients enough time to consider the information, to ask questions to the Investigator, their general practitioner (GP) or other independent parties to decide whether they wish to participate in the study or not.
For those interested in participation, a baseline assessment will be arranged to coincide with their standard pre-admission visit, for informed consent, screening and eligibility assessment. Moreover, a pre-operative imaging assessment with a cardiac computed tomography (CT) scan will be performed to define the left atrial (LA) and PV anatomy and to measure the baseline LA wall thickness and PVs ostial diameters.
All AF ablation procedures will be performed in a standard fashion by using radiofrequency (RF) energy, cryo-balloon or laser balloon ablation under general anaesthesia and with continuous oesophageal temperature monitoring. Ultrasound imaging by IVUS (Visions PV .018, 20 MHz digital probe, Volcano Corp) or ICE (Ultra ICE (9 MHz rotational transducer, Boston Scientific) will be performed at sites corresponding with the PV/LA junction at the beginning and the end of the procedure in order to measure acute changes in LA wall thickness and PV ostial diameters.
The cardiac CT will be repeated within 24 hours post-procedure. After the procedure, a pre-discharge review and a telephone follow-up at 1 week will be performed to identify any early and late complications related to the procedure.
A total of 14 patients will finally be enrolled in the study. The end of the study for each patient will be the date of the telephone follow-up 1 week after the procedure.
For each patient the pre-procedural and post-procedural CT measurements of LA wall thickness and PVs ostial diameters will be compared with the corresponding IVUS or ICE measurements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective atrial fibrillation (AF) ablation in view of a history of symptomatic and drug-refractory paroxysmal AF.
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| ICE/IVUS imaging during atrial fibrillation ablationIntravascular ultrasound imaging of the left atrial wall thickness with ICE/IVUS during atrial fibrillation ablation | Procedure or surgery | – |
Primary outcome
Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames
Time frame: Day 1
Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = [(vessel area - lumen area)/vessel area] x 100
Measurement of LA Wall Thickness on CT Scans
Time frame: 1 day
Left atrial wall thickness at the PV ostia, measured as Wall Thickness Index % = [(vessel area - lumen area)/vessel area] x 100
2 secondary outcomes
Mean Time Required for ICE/IVUS for Real Time Imaging of the Left Atrial (LA) Wall Thickness During AF Ablation
Time frame: Day 1
Number of ICE/IVUS Cases of Good Quality
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22381429Kowalski M, Grimes MM, Perez FJ, Kenigsberg DN, Koneru J, Kasirajan V, Wood MA, Ellenbogen KA. Histopathologic characterization of chronic radiofrequency ablation lesions for pulmonary vein isolation. J Am Coll Cardiol. 2012 Mar 6;59(10):930-8. doi: 10.1016/j.jacc.2011.09.076.
- Background: PubMed 11342752Schwartzman D, Ren JF, Devine WA, Callans DJ. Cardiac swelling associated with linear radiofrequency ablation in the atrium. J Interv Card Electrophysiol. 2001 Jun;5(2):159-66. doi: 10.1023/a:1011477408021.
- Background: PubMed 12975247Weerasooriya R, Jais P, Sanders P, Scavee C, Hsu LF, Hocini M, Clementy J, Haissaguerre M. Images in cardiovascular medicine. Early appearance of an edematous tissue reaction during left atrial linear ablation using intracardiac echo imaging. Circulation. 2003 Sep 16;108(11):e80. doi: 10.1161/01.CIR.0000083530.08597.B5. No abstract available.
- Background: PubMed 18181919Khairy P, Dubuc M. Transcatheter cryoablation part I: preclinical experience. Pacing Clin Electrophysiol. 2008 Jan;31(1):112-20. doi: 10.1111/j.1540-8159.2007.00934.x. No abstract available.
- Background: PubMed 9787063Gage AA, Baust J. Mechanisms of tissue injury in cryosurgery. Cryobiology. 1998 Nov;37(3):171-86. doi: 10.1006/cryo.1998.2115.
- Background: PubMed 12668527Khairy P, Chauvet P, Lehmann J, Lambert J, Macle L, Tanguay JF, Sirois MG, Santoianni D, Dubuc M. Lower incidence of thrombus formation with cryoenergy versus radiofrequency catheter ablation. Circulation. 2003 Apr 22;107(15):2045-50. doi: 10.1161/01.CIR.0000058706.82623.A1. Epub 2003 Mar 31.
- Background: PubMed 19546385Reddy VY, Neuzil P, Themistoclakis S, Danik SB, Bonso A, Rossillo A, Raviele A, Schweikert R, Ernst S, Kuck KH, Natale A. Visually-guided balloon catheter ablation of atrial fibrillation: experimental feasibility and first-in-human multicenter clinical outcome. Circulation. 2009 Jul 7;120(1):12-20. doi: 10.1161/CIRCULATIONAHA.108.840587. Epub 2009 Jun 22.
- Background: PubMed 17226084Hall B, Jeevanantham V, Simon R, Filippone J, Vorobiof G, Daubert J. Variation in left atrial transmural wall thickness at sites commonly targeted for ablation of atrial fibrillation. J Interv Card Electrophysiol. 2006 Nov;17(2):127-32. doi: 10.1007/s10840-006-9052-2. Epub 2007 Jan 17.
- Background: PubMed 17397672Okada T, Yamada T, Murakami Y, Yoshida N, Ninomiya Y, Shimizu T, Toyama J, Yoshida Y, Ito T, Tsuboi N, Kondo T, Inden Y, Hirai M, Murohara T. Prevalence and severity of left atrial edema detected by electron beam tomography early after pulmonary vein ablation. J Am Coll Cardiol. 2007 Apr 3;49(13):1436-42. doi: 10.1016/j.jacc.2006.10.076. Epub 2007 Mar 21.
- Background: PubMed 25863159Granier M, Winum PF, Granier M, Liaud P, Cayla G, Messner P, Pasquie JL, Schuster I. Real-time atrial wall imaging during radiofrequency ablation in a porcine model. Heart Rhythm. 2015 Aug;12(8):1827-35. doi: 10.1016/j.hrthm.2015.04.012. Epub 2015 Apr 8.
- Background: PubMed 11567596Ren JF, Callans DJ, Schwartzman D, Michele JJ, Marchlinski FE. Changes in local wall thickness correlate with pathologic lesion size following radiofrequency catheter ablation: an intracardiac echocardiographic imaging study. Echocardiography. 2001 Aug;18(6):503-7. doi: 10.1046/j.1540-8175.2001.00503.x.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Tim Betts, MD principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 6 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 18 Apr 2024. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames (time frame: Day 1). The study lists 2 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 NCT03372798, 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 18 Apr 2024.