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Contact Force Sensing and Pulmonary Vein Isolation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:
Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01630031
Study type Observational
Source Clinique Pasteur
Contact
Status Active, not recruiting
Phase N/A
Start date November 2010
Completion date November 2012
View Details
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