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Af Ablation In Brady-Tachy Syndrome (Alternative)

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ClinicalTrials.gov Identifier: NCT00740272
Recruitment Status : Terminated (Slow recruitment)
First Posted : August 22, 2008
Last Update Posted : October 18, 2011
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

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.


Condition or disease Intervention/treatment Phase
Brady-tachy Syndrome Procedure: AF ablation + pacemaker implantation Procedure: Pacemaker implantation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Af Ablation In Brady-Tachy Syndrome
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. AF burden [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740272


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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00740272     History of Changes
Other Study ID Numbers: SJM-FR01
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: October 18, 2011
Last Verified: October 2011

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