Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Device: Navistar catheter; Device: nMARQ catheter

• Registration Number: NCT02107027
• Lead Sponsor: Association de Recherche pour le Traitement des Arythmies Cardiaques

Brief Summary

The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation.

Currently, two technologies of irrigated ablation catheters are available for PVI.

One of the two, the "conventional" catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming.

The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way.

These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2016-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-29
• Last Update Posted: 2017-07-02
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation.
• Age superior or equal to 18 years old, both genders.
• Patient's oral agreement for study participation after reading information note.
• Patient affiliated or recipient of a social welfare regimen.

Exclusion Criteria

• Age inferior to 18 years old
• Pregnancy
• Unbalanced psychiatric disorders
• Contraindication to atrial fibrillation ablation by endocardial way.
• Redo-ablation
• No patient's oral agreement for study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Navistar catheter (conventional catheter)	Navistar catheter	Group treated with the conventional ablation catheter for atrial fibrillation ablation
nMARQ catheter (circular catheter)	nMARQ catheter	Group treated with the circular ablation catheter for atrial fibrillation ablation

Primary Outcome Measures

Name	Time	Method
Number of Pulmonary veins reconnection	End of ablation procedure	Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4)

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Pessac, France