Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— EVACIRC  

Official title:

Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02107027
• Other study ID #: EVACIRC
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2014
• Last updated: June 29, 2017
• Start date: March 2013
• Est. completion date: September 2018

Study information

• Verified date: June 2017
• Source: Association de Recherche pour le Traitement des Arythmies Cardiaques
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: September 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• nMARQ catheter
In this arm the circular ablation catheter will be used for a quick mapping of left atrium with Carto system. The catheter will be positioned to pulmonary veins ostium to deliver radiofrequency on 1 to 10 electrodes simultaneous. The same catheter will be used to document pulmonary veins isolation (PVI). A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) site(s) will be noted.
• Navistar catheter
In this arm the conventional catheter will be used. It will be used for a left atrium quick mapping on Carto system. Radiofrequency will be delivered in a sequential manner in pulmonary veins for point by point ablation. Isolation will be guided and confirmed with the Lasso decapolar diagnostic catheter (Biosense Webster, Diamond Bar, USA). A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) sites will be noted.

Locations

Country	Name	City	State
France	CHU Bordeaux	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Association de Recherche pour le Traitement des Arythmies Cardiaques

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Pulmonary veins reconnection	Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4)	End of ablation procedure