Contact Force Sensing and Pulmonary Vein Isolation
Recruitment status was: Active, not recruiting
Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome.
Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for PVI.
Methods - Prospective observational non-randomized monocentric study. Patients with paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. All procedures is performed by the same experienced operator, not blinded to the catheter used. Except for CF information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled in a specific follow-up plan.
Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of patients free of AF after 12-month follow-up.
Paroxysmal Atrial Fibrillation
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation|
- Proportion of PVI after exclusive anatomic approach [ Time Frame: Day 0 ]
- Proportion of patients free of AF after 12-month FU [ Time Frame: One year ]
- Total time of fluoroscopy and radiation exposure [ Time Frame: Day 0 ]
- Total time of RF application required for completed PVI [ Time Frame: Day 0 ]
- Proportion of pericardial effusion at echocardiography [ Time Frame: Day 1 ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.
Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630031
|Toulouse, France, 31076|
|Principal Investigator:||Jean-Paul Albenque, M.D.||Clinique Pasteur|