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

June 29, 2017 updated by: Association de Recherche pour le Traitement des Arythmies Cardiaques

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33600
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: nMARQ catheter (circular catheter)
Group treated with the circular ablation catheter for atrial fibrillation ablation
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.
Active Comparator: Navistar catheter (conventional catheter)
Group treated with the conventional ablation catheter for atrial fibrillation ablation
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Pulmonary veins reconnection
Time Frame: End of ablation procedure
Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4)
End of ablation procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association de Recherche pour le Traitement des Arythmies Cardiaques

Investigators

  • Principal Investigator: Pierre JAIS, MD, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVACIRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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