Af Ablation In Brady-Tachy Syndrome (Alternative)

Abbott

Status: Terminated

Conditions: Brady-tachy Syndrome

Treatments: Procedure: AF ablation + pacemaker implantation; Procedure: Pacemaker implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00740272

SJM-FR01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

1

Experimental group

Description:

AF ablation + pacemaker

Treatment:

Procedure: AF ablation + pacemaker implantation

2

Active Comparator group

Description:

Pacemaker

Treatment:

Procedure: Pacemaker implantation