Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation (EVACIRC)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nMARQ catheter
Navistar catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- CHU Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
nMARQ catheter (circular catheter)
Navistar catheter (conventional catheter)
Arm Description
Group treated with the circular ablation catheter for atrial fibrillation ablation
Group treated with the conventional ablation catheter for atrial fibrillation ablation
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02107027
First Posted
March 31, 2014
Last Updated
June 29, 2017
Sponsor
Association de Recherche pour le Traitement des Arythmies Cardiaques
1. Study Identification
Unique Protocol Identification Number
NCT02107027
Brief Title
Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
Acronym
EVACIRC
Official Title
Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association de Recherche pour le Traitement des Arythmies Cardiaques
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nMARQ catheter (circular catheter)
Arm Type
Active Comparator
Arm Description
Group treated with the circular ablation catheter for atrial fibrillation ablation
Arm Title
Navistar catheter (conventional catheter)
Arm Type
Active Comparator
Arm Description
Group treated with the conventional ablation catheter for atrial fibrillation ablation
Intervention Type
Device
Intervention Name(s)
nMARQ catheter
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Navistar catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Pulmonary veins reconnection
Description
Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4)
Time Frame
End of ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre JAIS, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
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