NCT02107027

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

March 31, 2014

Last Update Submit

June 29, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

nMARQ catheter (circular catheter)

ACTIVE COMPARATOR

Group treated with the circular ablation catheter for atrial fibrillation ablation

Device: nMARQ catheter

Navistar catheter (conventional catheter)

ACTIVE COMPARATOR

Group treated with the conventional ablation catheter for atrial fibrillation ablation

Device: Navistar catheter

Interventions

nMARQ catheterDEVICE

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.

nMARQ catheter (circular catheter)
Navistar catheterDEVICE

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.

Navistar catheter (conventional catheter)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Pessac, 33600, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre JAIS, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 8, 2014

Study Start

March 1, 2013

Primary Completion

July 1, 2016

Study Completion

September 1, 2018

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

FR(1)