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

NCT ID: NCT03389633

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 462 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-01
• Study Completion Date: 2016-07-31

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

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitation group

this group follows a 3 months rehab program

Group Type: EXPERIMENTAL

rehabilitation

Intervention Type: OTHER

No rehabilitation

This group does not follow a rehab program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

rehabilitation

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

prof. dr. Paul Dendale

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Paul Dendale

Professor of cardiovascular pathophysiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul Dendale, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Other Identifiers

16.46/cardio16.08

Identifier Type: -

Identifier Source: org_study_id