Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation (EVACIRC)

Association de Recherche pour le Traitement des Arythmies Cardiaques

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Device: Navistar catheter; Device: nMARQ catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02107027

EVACIRC

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

nMARQ catheter (circular catheter)

Active Comparator group

Description:

Group treated with the circular ablation catheter for atrial fibrillation ablation

Treatment:

Device: nMARQ catheter

Navistar catheter (conventional catheter)

Active Comparator group

Description:

Group treated with the conventional ablation catheter for atrial fibrillation ablation

Treatment:

Device: Navistar catheter