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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Syndrome
Sick Sinus Syndrome
Disease
Pathologic Processes
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block

ClinicalTrials.gov processed this record on September 22, 2014