Af Ablation In Brady-Tachy Syndrome

NCT ID: NCT00740272

Last Updated: 2019-02-04

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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The aim of the study is to evaluate the impact of atrial fibrillation ablation in patients presenting a brady-tachy syndrome on the AF burden.

The hypothesis of the study is that AF ablation prevents not only from AF episodes recurrence but also from bradycardic episodes.

Detailed Description

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The study is a randomized study 1:1 AF ablation vs non AF ablation. Patients are followed for 1 year. 38 patients will be required to show a significant reduction in AF burden.

Conditions

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Brady-tachy Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

AF ablation + pacemaker

Group Type EXPERIMENTAL

AF ablation + pacemaker implantation

Intervention Type PROCEDURE

regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)

2

Pacemaker

Group Type ACTIVE_COMPARATOR

Pacemaker implantation

Intervention Type PROCEDURE

regular pacemaker implantation

Interventions

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AF ablation + pacemaker implantation

regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)

Intervention Type PROCEDURE

Pacemaker implantation

regular pacemaker implantation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* paroxystic AF
* symptomatic pauses (\>5s at night or 3s during daytime)

Exclusion Criteria

* permanent AF
* age \> 80 y
* pregnant women
* minors
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital St joseph

Marseille, , France

Site Status

CHU

Rouen, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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SJM-FR01

Identifier Type: -

Identifier Source: org_study_id

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