This trial is active, not recruiting.

Conditions paroxysmal atrial fibrillation, catheter ablation
Sponsor Clinique Pasteur
Start date November 2010
End date November 2012
Trial size 60 participants
Trial identifier NCT01630031, 1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.
Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Symptomatic paroxysmal atrial fibrillation despite at least failure of one anti-arrhythmic drug - Age 18-75 yrs - First catheter ablation Exclusion Criteria: - Left ventricle ejection fraction at echocardiography <50% - History of heart surgery

Additional Information

Official title Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation
Principal investigator Jean-Paul Albenque, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Clinique Pasteur.