Af Ablation In Brady-Tachy Syndrome (Alternative)

This study has been terminated.
(Slow recruitment)
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00740272
First received: August 20, 2008
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Brady-tachy Syndrome
Procedure: AF ablation + pacemaker implantation
Procedure: Pacemaker implantation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Af Ablation In Brady-Tachy Syndrome

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • AF burden [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AF ablation + pacemaker
Procedure: AF ablation + pacemaker implantation
regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)
Active Comparator: 2
Pacemaker
Procedure: Pacemaker implantation
regular pacemaker implantation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • permanent AF
  • age > 80 y
  • pregnant women
  • minors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740272

Locations
France
Hôpital St joseph
Marseille, France
CHU
Rouen, France
Clinique Pasteur
Toulouse, France
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00740272     History of Changes
Other Study ID Numbers: SJM-FR01
Study First Received: August 20, 2008
Last Updated: October 17, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by St. Jude Medical:
brady-tachy syndrome
AF ablation

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014