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OpenTrials
Completed

NCT Number: NCT03389633

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rehabilitation

Other

Primary outcomes

  1. Number of recurrences of atrial fibrillation or need for new ablation

    Time frame: from 3 months after discharge until 1 year

    idem

Secondary outcomes

  1. The proportion of patients who needed to continue treatment with antiarrhythmics

    Time frame: month 3 until one year

Sponsors and collaborators

Lead sponsor

prof. dr. Paul Dendale

Other

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Jan 3, 2018
Registry last updated
Jan 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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