Impact of Life-Style Modification On Ablation Outcome in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Arrhythmia recurrence
研究概览
简要总结
This prospective randomized pilot study aims to evaluate the impact of aggressive life style modification in terms of calorie-controlled diet and supervised exercise on outcome of catheter ablation in overweight and obese patients with atrial fibrillation.
Hypothesis: Weight loss and management by adoption of strict diet and exercise regimen improves the chances of freedom from recurrence following catheter ablation.
详细描述
Objective: To examine the impact of a planned life-style modification program including calorie-controlled diet and supervised exercise before and after the AF ablation on quality of life (QoL) and long-term arrhythmia recurrence in overweight and obese patients with atrial fibrillation.
Endpoints:
Primary: AF recurrence following index ablation procedure It will be assessed at 3, 6 and 12 months after the procedure by event recorders, 12-lead ECG and Holter monitoring Any episode of AF/AFL/AT > 30 sec will be considered as a recurrence. Episodes that occur during the first 3 months after the procedure (blanking period) will not be considered as recurrence.
Secondary:
- Change in QoL It will be evaluated by a validated AF specific questionnaire (AFEQT) at baseline and 6 and 12 months post-procedure
- Change in AF symptom severity. This will be measured by AF symptom severity and burden questionnaire at baseline and 6 and 12 months post-procedure
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > 18 years
- •AF patient undergoing first catheter ablation, at least 3 months after the enrollment
- •BMI: ≥ 26-40
- •Willing to be compliant with the weight-reduction program
- •Willing to provide informed, written consent
排除标准
- •Chronic obstructive lung disease (COPD)
- •Participation in another weight loss program in < 3 months
- •Musculoskeletal conditions limiting exercise capacity
- •Insulin-dependent diabetes
- •Severe valvular heart disease or cardiomyopathy
- •Heavy drinking (>14 standard drinks/week for men and >7/ week for women)
- •Inability to provide informed consent
结局指标
主要结局
Arrhythmia recurrence
时间窗: 1 year post-ablation
Arrhythmia recurrence will be monitored at 3-month intervals with Holter monitor, event recorder, cardiology evaluation and ECG. Recurrence is defined as any episode of AF/ atrial flutter/ atrial tachycardia of \>30 seconds duration with or without anti-arrhythmic drugs, occurring after 3 months of blanking period following catheter ablation
次要结局
- Quality of Life(1 year)