Clinical Trials Logo
  1. Home
  2. Paroxysmal Atrial Fibrillation
  3. NCT01630031

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
See also
  Status Clinical Trial Phase
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Recruiting NCT06014996 - Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation. N/A
Completed NCT03624881 - Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU) Phase 4
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Recruiting NCT05905835 - Treatment of PAF With the Synaptic System N/A
Active, not recruiting NCT05618340 - PFA for Paroxysmal Atrial Fibrillation N/A
Active, not recruiting NCT05534581 - SINGLE SHOT CHAMPION Phase 4
Not yet recruiting NCT05024630 - Renal Denervation and pUlmonary Vein isolAtion With cryoabLation on Patients With Atrial Fibrillation and hypErtension N/A
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Completed NCT01913522 - Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration N/A
Terminated NCT01925885 - Focal Impulse and Rotor Modulation Ablation Trial for Treatment of Paroxysmal Atrial Fibrillation (FIRMAT-PAF) N/A
Withdrawn NCT01917981 - Testing the Accuracy of a Personal Heart Rhythm Monitor to Detect Prolonged Paroxysmal Atrial Fibrillation Phase 3
Completed NCT01693107 - Atrial Fibrillation Force Contact Ablation Study
Completed NCT01842529 - Botulinum Toxin Injection in Epicardial Fat Pads To Treat Atrial Fibrillation After Cardiac Surgery Phase 2
Completed NCT00971204 - Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation Phase 2
Completed NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System N/A
Recruiting NCT05172765 - Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF) N/A
Recruiting NCT04529785 - Added Value of Vein of Marshal Ethanol Infusion Compared to Superior Vena Cava Isolation Alone in Patients Undergoing Repeat Ablation for Recurrent Paroxysmal Atrial Fibrillation Despite Durable PV Isolation N/A
Completed NCT04022954 - HD Mapping of Atrial Fibrillation in Asia Pacific
Completed NCT00964392 - NAVISTAR® THERMOCOOL® Catheter Post Approval Registry Phase 4