Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
NCT ID: NCT02107027
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
58 participants
INTERVENTIONAL
2013-03-31
2018-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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nMARQ catheter (circular catheter)
Group treated with the circular ablation catheter for atrial fibrillation ablation
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 (conventional catheter)
Group treated with the conventional ablation catheter for atrial fibrillation ablation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
* Unbalanced psychiatric disorders
* Contraindication to atrial fibrillation ablation by endocardial way.
* Redo-ablation
* No patient's oral agreement for study participation
18 Years
ALL
No
Sponsors
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Association de Recherche pour le Traitement des Arythmies Cardiaques
OTHER
Responsible Party
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Principal Investigators
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Pierre JAIS, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU Bordeaux
Pessac, , France
Countries
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Other Identifiers
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EVACIRC
Identifier Type: -
Identifier Source: org_study_id
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