Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- an ablation for AF (Atrial fibrillation)
Exclusion Criteria:
- a complicated ablation
- a prosthetic heart valve
- a severe valvulopathy,
- hyperthyroidism at the time of the ablation,
- pregnancy and breastfeeding,
- intensive sport (more than 1 hour a day),
- a myocardial infarction or a thromboembolic event within 3 months after the ablation,
- a pacemaker
- end-stage renal disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Rehabilitation group
No rehabilitation
Arm Description
this group follows a 3 months rehab program
This group does not follow a rehab program
Outcomes
Primary Outcome Measures
Number of recurrences of atrial fibrillation or need for new ablation
idem
Secondary Outcome Measures
The proportion of patients who needed to continue treatment with antiarrhythmics
Full Information
NCT ID
NCT03389633
First Posted
December 20, 2017
Last Updated
January 2, 2018
Sponsor
prof. dr. Paul Dendale
1. Study Identification
Unique Protocol Identification Number
NCT03389633
Brief Title
Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
Official Title
Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2007 (Actual)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
prof. dr. Paul Dendale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many risk factors contribute to the onset of atrial fibrillation. This study is specifically concerned with the effect of addressing these risk factors by cardiac rehabilitation on the risk of recurrence of atrial fibrillation following catheter ablation. A non-randomized, retrospective study was performed on patients treated with a catheter ablation for atrial fibrillation. The intervention group consisted of patients who chose to participate in the cardiac rehabilitation program. The control group only received standard care. The primary objective was to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation resulted in a reduction of the time to or the risk of recurrence of atrial fibrillation or the need for a second ablation within 1 year after the first ablation. A Kaplan-Meier analysis was used to examine the primary objective. The secondary objectives of this study were to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation had an effect on the evolution of the patients' BMI (a Mann-Whitney U test), the number of recurrences of atrial fibrillation (a Poisson regression) and the proportion of patients who need to continue treatment with antiarrhythmics 3 months following the first ablation (a chi-square test).
Detailed Description
The intervention group follows a 3 months rehab program consisting of training, education, coaching and medical follow-up. The control group are patients that chose not to follow this program. This is a retrospective non randomized trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
462 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation group
Arm Type
Experimental
Arm Description
this group follows a 3 months rehab program
Arm Title
No rehabilitation
Arm Type
No Intervention
Arm Description
This group does not follow a rehab program
Intervention Type
Other
Intervention Name(s)
rehabilitation
Primary Outcome Measure Information:
Title
Number of recurrences of atrial fibrillation or need for new ablation
Description
idem
Time Frame
from 3 months after discharge until 1 year
Secondary Outcome Measure Information:
Title
The proportion of patients who needed to continue treatment with antiarrhythmics
Time Frame
month 3 until one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
an ablation for AF (Atrial fibrillation)
Exclusion Criteria:
a complicated ablation
a prosthetic heart valve
a severe valvulopathy,
hyperthyroidism at the time of the ablation,
pregnancy and breastfeeding,
intensive sport (more than 1 hour a day),
a myocardial infarction or a thromboembolic event within 3 months after the ablation,
a pacemaker
end-stage renal disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Dendale, prof. dr.
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
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