Contact Force Sensing and Pulmonary Vein Isolation
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|ClinicalTrials.gov Identifier: NCT01630031|
Recruitment Status : Unknown
Verified June 2012 by JP Albenque, Clinique Pasteur.
Recruitment status was: Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
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.
|Condition or disease|
|Paroxysmal Atrial Fibrillation Catheter Ablation|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||November 2012|
Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.
Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630031
|Toulouse, France, 31076|
|Principal Investigator:||Jean-Paul Albenque, M.D.||Clinique Pasteur|