Af Ablation In Brady-Tachy Syndrome

Not Applicable

Terminated

• Conditions: Brady-tachy Syndrome
• Interventions: Procedure: AF ablation + pacemaker implantation; Procedure: Pacemaker implantation

• Registration Number: NCT00740272
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

Exclusion Criteria

• permanent AF
• age > 80 y
• pregnant women
• minors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AF ablation + pacemaker implantation	AF ablation + pacemaker
2	Pacemaker implantation	Pacemaker

Primary Outcome Measures

Name	Time	Method
AF burden	1 year

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 year

Trial Locations

Locations (3)

Hôpital St joseph; 🇫🇷 Marseille, France

CHU; 🇫🇷 Rouen, France

Clinique Pasteur; 🇫🇷 Toulouse, France