Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: rehabilitation

• Registration Number: NCT03389633
• Lead Sponsor: prof. dr. Paul Dendale

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

Study Timeline

• Study Start: 2007-01-01
• Primary Completion: 2016-07-31
• Study Completion: 2016-07-31
• Status Verified: 2017-12
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-01-02
• Last Update Submitted: 2018-01-02
• Study First Posted: 2018-01-03
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation group	rehabilitation	this group follows a 3 months rehab program

Primary Outcome Measures

Name	Time	Method
Number of recurrences of atrial fibrillation or need for new ablation	from 3 months after discharge until 1 year	idem

Secondary Outcome Measures

Name	Time	Method
The proportion of patients who needed to continue treatment with antiarrhythmics	month 3 until one year