Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 462
- 主要终点
- Number of recurrences of atrial fibrillation or need for new ablation
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an ablation for AF (Atrial fibrillation)
排除标准
- •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.
研究组 & 干预措施
Rehabilitation group
this group follows a 3 months rehab program
干预措施: rehabilitation (Other)
No rehabilitation
This group does not follow a rehab program
结局指标
主要结局
Number of recurrences of atrial fibrillation or need for new ablation
时间窗: from 3 months after discharge until 1 year
idem
次要结局
- The proportion of patients who needed to continue treatment with antiarrhythmics(month 3 until one year)
研究者
prof. dr. Paul Dendale
Professor of cardiovascular pathophysiology
Hasselt University
