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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICE/IVUS imaging during atrial fibrillation ablation | Procedure | Intravascular ultrasound imaging of the left atrial wall thickness with ICE/IVUS during atrial fibrillation ablation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 |
| Number of ICE/IVUS Cases of Good Quality |
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Inclusion Criteria
Exclusion Criteria
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Patients scheduled for elective atrial fibrillation (AF) ablation in view of a history of symptomatic and drug-refractory paroxysmal AF.
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| Name | Affiliation | Role |
|---|---|---|
| Tim Betts, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22381429 | Background | 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. | |
| 11342752 | Background | Schwartzman 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. |
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Two recruited patients were not included in the data analysis because of
Recruitment performed from November 2016 to October 2017 in Cardiology Outpatient Clinic.
A total of 14 patients enrolled. 2 patients had incomplete datasets so 12 patients available for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intracardiac Echo (ICE) Imaging | Pulmonary vein imaging performed during atrial fibrillation ablation with ICE |
| FG001 | Intravascular Ultrasound (IVUS) Imaging | Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intracardiac Echo (ICE) Imaging | Pulmonary vein imaging performed during atrial fibrillation ablation with ICE |
| BG001 | Intravascular Ultrasound (IVUS) Imaging | Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Median | Inter-Quartile Range | percentage | Day 1 |
|
Day of catheter ablation procedure and one week after the procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intracardiac Echo (ICE) Imaging | Pulmonary vein imaging performed during atrial fibrillation ablation with ICE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tim Betts | Oxford University Hospitals NHS Foundation Trust | 0044 01865 220256 | ep.doctors@ouh.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2016 | Sep 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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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. |
| Day 1 |
| 12975247 | Background | Weerasooriya 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. |
| 18181919 | Background | Khairy 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. |
| 9787063 | Background | Gage AA, Baust J. Mechanisms of tissue injury in cryosurgery. Cryobiology. 1998 Nov;37(3):171-86. doi: 10.1006/cryo.1998.2115. |
| 12668527 | Background | Khairy 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. |
| 19546385 | Background | Reddy 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. |
| 17226084 | Background | Hall 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. |
| 17397672 | Background | Okada 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. |
| 25863159 | Background | Granier 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. |
| 11567596 | Background | Ren 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ablation modality for Pulmonary Vein Isolation | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | 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 | The analysis was not possible as the CT images were inadvertently deleted before any analysis was performed. | Posted | 1 day |
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | minutes | Day 1 |
|
|
|
| Secondary | 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. | Posted | Count of Units | Pulmonary Vein cross-sections | Day 1 | Pulmonary Vein cross-sections | Pulmonary Vein cross-sections |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Intravascular Ultrasound (IVUS) Imaging | Pulmonary vein imaging performed during atrial fibrillation ablation with IVUS | 0 | 5 | 0 | 5 | 0 | 5 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Laser energy |
|