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临床试验/NCT03389633
NCT03389633已完成不适用

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

prof. dr. Paul Dendale0 个研究点目标入组 462 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

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

Experimental

this group follows a 3 months rehab program

干预措施: rehabilitation (Other)

No rehabilitation

No Intervention

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

发起方
prof. dr. Paul Dendale
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

prof. dr. Paul Dendale

Professor of cardiovascular pathophysiology

Hasselt University

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