Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 5:34 AM
Study NCT ID:
NCT03389633
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
Sponsor:
prof. dr. Paul Dendale
Organization:
Study Overview
Official Title:
Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: