Pre-habilitation Multicomponent Lifestyle Program for Patients Undergoing Ablation for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Cardiac Rehab Sessions Attended
研究概览
简要总结
The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Paroxysmal or persistent atrial fibrillation.
- •Planned elective catheter ablation of AF.
排除标准
- •Prior catheter ablation.
- •Presence of pacemaker/ICD.
- •Longstanding persistent AF.
- •Uncontrolled AF (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment).
研究组 & 干预措施
Lifestyle Interventions Pre-Procedure
Subjects with paroxysmal or persistent atrial fibrillation (AF) who are scheduled to undergo elective catheter ablation of AF will participate in a 12-week multicomponent lifestyle intervention program.
干预措施: Multicomponent lifestyle intervention program (Behavioral)
Standard of Care
Subjects who have previously undergone catheter ablation of atrial fibrillation (AF) as part of their standard of care will have medical chart review completed to gather information.
结局指标
主要结局
Number of Cardiac Rehab Sessions Attended
时间窗: 12 weeks
Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program.
次要结局
- Change in weight loss(Baseline, 12 weeks)
- Number of subjects with Atrial Fibrillation (AF) recurrence(1 year)
- Change in exercise capacity(Baseline, 12 weeks)
- Change in Atrial Fibrillation (AF) Symptom severity(Baseline, 12 weeks, 6 months, 1 year)
研究者
Amanda R. Bonikowske
Principal Investigator
Mayo Clinic