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

P

prof. dr. Paul Dendale

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Other: rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT03389633
16.46/cardio16.08

Details and patient eligibility

About

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).

Full 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

Enrollment

462 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

462 participants in 2 patient groups

Rehabilitation group
Experimental group
Description:
this group follows a 3 months rehab program
Treatment:
Other: rehabilitation
No rehabilitation
No Intervention group
Description:
This group does not follow a rehab program

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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