Af Ablation In Brady-Tachy Syndrome (Alternative)
Primary Purpose
Brady-tachy Syndrome
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AF ablation + pacemaker implantation
Pacemaker implantation
Sponsored by
About this trial
This is an interventional treatment trial for Brady-tachy Syndrome focused on measuring brady-tachy syndrome, AF ablation
Eligibility Criteria
Inclusion Criteria:
- paroxystic AF
- symptomatic pauses (>5s at night or 3s during daytime)
Exclusion Criteria:
- permanent AF
- age > 80 y
- pregnant women
- minors
Sites / Locations
- Hôpital St joseph
- CHU
- Clinique Pasteur
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
AF ablation + pacemaker
Pacemaker
Outcomes
Primary Outcome Measures
AF burden
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT00740272
First Posted
August 20, 2008
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00740272
Brief Title
Af Ablation In Brady-Tachy Syndrome
Acronym
Alternative
Official Title
Af Ablation In Brady-Tachy Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brady-tachy Syndrome
Keywords
brady-tachy syndrome, AF ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AF ablation + pacemaker
Arm Title
2
Arm Type
Active Comparator
Arm Description
Pacemaker
Intervention Type
Procedure
Intervention Name(s)
AF ablation + pacemaker implantation
Intervention Description
regular pacemaker implantation and concomitant AF ablation procedure (PV isolation)
Intervention Type
Procedure
Intervention Name(s)
Pacemaker implantation
Intervention Description
regular pacemaker implantation
Primary Outcome Measure Information:
Title
AF burden
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
paroxystic AF
symptomatic pauses (>5s at night or 3s during daytime)
Exclusion Criteria:
permanent AF
age > 80 y
pregnant women
minors
Facility Information:
Facility Name
Hôpital St joseph
City
Marseille
Country
France
Facility Name
CHU
City
Rouen
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
Af Ablation In Brady-Tachy Syndrome
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