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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389633
• Other study ID #: 16.46/cardio16.08
• Status: Completed
• Phase: N/A
• First received: December 20, 2017
• Last updated: January 2, 2018
• Start date: January 1, 2007
• Est. completion date: July 31, 2016

Study information

• Verified date: December 2017
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: July 31, 2016
• Est. primary completion date: July 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Other:
• rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
prof. dr. Paul Dendale

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of recurrences of atrial fibrillation or need for new ablation	idem	from 3 months after discharge until 1 year
Secondary	The proportion of patients who needed to continue treatment with antiarrhythmics		month 3 until one year