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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Notify MeKey information
Conditions
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
Primary outcomes
-
Number of recurrences of atrial fibrillation or need for new ablation
Time frame: from 3 months after discharge until 1 year
idem
Secondary outcomes
-
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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