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Clinical Trials/NCT00740272
NCT00740272TerminatedNot Applicable

Af Ablation In Brady-Tachy Syndrome

Abbott Medical Devices3 sites in 1 country38 target enrollmentStarted: March 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
38
Locations
3
Primary Endpoint
AF burden
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

1

Experimental

AF ablation + pacemaker

Intervention: AF ablation + pacemaker implantation (Procedure)

2

Active Comparator

Pacemaker

Intervention: Pacemaker implantation (Procedure)

Outcomes

Primary Outcomes

AF burden

Time Frame: 1 year

Secondary Outcomes

  • Quality of life(1 year)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (3)

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Af Ablation In Brady-Tachy Syndrome | Clinical Trial