Efficiency Study Evaluating the Use of PVAC Catheter Technology for Performing Ablation in Pts With Atrial Fibrillation (CAPCOST)
|ClinicalTrials.gov Identifier: NCT01562912|
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : March 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Radiofrequency Ablation Procedure Device: PVAC Ablation Procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Prospective, Multicenter Canadian Atrial Fibrillation PVAC Cohort Study|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||March 2018|
Active Comparator: Control
Radiofrequency Ablation Procedure. Subjects who are undergoing AF ablation with traditional ablation technology at the same centers by the same operators. Control patients will be enrolled in a 1:2 ratio compared to the PVAC cohort. Intervention is the use of Radiofrequency Ablation.
Device: Radiofrequency Ablation Procedure
Application of radiofrequency energy will be delivered during PV antral isolation procedure and should be performed with a standard, open irrigated ablation catheter and a mapping system as the investigator would perform the procedure normally.
Experimental: PVAC Ablation Procedure
Intervention is the use of PVAC technology. The PVAC is deployed in the left atrium over a 0.032-inch guidewire inside the PV and advanced until it is wedged within the antrum proximal to the ostium. Energy is delivered through selected electrode pairs with local potentials as well as adjacent electrode pairs, allowing bipolar current to flow to the target electrode(s) from both sides. Each application lasts for 60 seconds. When the temperature does not rise above 50°C within 15 seconds, the application should be discontinued to improve position. The PVAC may be manipulated within the antrum to ablate in a pattern of overlapping circular lesions.
Device: PVAC Ablation Procedure
Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter(PVAC)to eliminate potentials arising from the pulmonary veins.
Other Name: PVAC Catheter, Medtronic Inc., Ablation Frontiers
- Procedure Duration and Fluoroscopy time [ Time Frame: At the time of the initial ablation procedure and repeat ablations. ]Length of procedure measure in hours/minutes and use of fluoroscopy measured in minutes
- Incidence of emergency room visits, hospitalizations and urgent clinic visits. [ Time Frame: 1 year follow-up post ablation ]Incidence of emergency room visits, hospitalizations and urgent clinic visits one year prior to ablation and 3, 6, 9, and 12 months post ablation.
- Quality of Life measurements (CCS-SAF, AFEQT and SF-12) [ Time Frame: 1 year post ablation ]Quality of Life measurements (CCS-SAF , AFEQT and SF-12) questionnaires at baseline, 3, 6 , 9 and 12 months.
- Total ablation procedure costs. [ Time Frame: 1 year post ablation ]calculation of procedural costs
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562912
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada|
|London Health Sciences Center|
|London, Ontario, Canada, N6A 5A5|
|Southlake Regional Health Centre|
|Newmarket, Ontario, Canada, L3Y 2P9|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H3G 1A4|
|Hôpital Sacré-Coeur de Montréal|
|Montreal, Quebec, Canada, H4J 1C5|
|Institut universitaire de cardiologie et de pneumologie de Québec|
|Quebec City, Quebec, Canada, G1V 4G5|
|Principal Investigator:||Atul Verma, MD||Newmarket Electrophysiology Research Group|