Effects of Positive Airway Pressure on Atrial Fibrillation Recurrence Risk After Catheter Ablation in Patients With Atrial Fibrillation and Obstructive Sleep Apnea-A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Atrial Fibrillation recurrence
研究概览
简要总结
With this pilot study, we are hoping to test the feasibility of a larger study in the future and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial fibrillation after successful catheter ablation procedure among patients with atrial fibrillation and obstructive sleep apnea. The results from this study will help us refine the design for a future larger study, and will ultimately improve care of patients with obstructive sleep apnea and atrial fibrillation.
详细描述
Obstructive sleep apnea, a sleep-related breathing disorder in which breathing stops for short periods during sleep, is a common condition in patients with atrial fibrillation. Studies have shown that up to 75% of atrial fibrillation patients undergoing catheter ablation procedure have obstructive sleep apnea. Obstructive sleep apnea increases the risk of atrial fibrillation recurrence after successful catheter ablation by 40%. However, whether treatment of obstructive sleep apnea with positive airway pressure (PAP, the current most effective treatment for obstructive sleep apnea that uses a machine to help breathe more easily) reduces the risk of atrial fibrillation recurrence is not fully understood. The purpose of this study, therefore, is to examine whether positive airway pressure therapy reduces atrial fibrillation recurrence after catheter ablation in patients with obstructive sleep apnea and atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •Men and women 18 years or older
- •First-time catheter ablation for atrial fibrillation
- •Moderate-to-severe obstructive sleep apnea diagnosed with a sleep study (apnea-hypopnea index ≥ 15)
排除标准
- •Current or prior use of positive airway pressure for obstructive sleep apnea
- •Any household member with current/past positive airway pressure use
- •Did not meet minimal adherence to positive airway pressure treatment (≥ 4 hours/night and ≥ 70% of time in 2 weeks)
- •History of motor vehicle or occupational accident related to excessive sleepiness
- •Severe nocturnal desaturation documented on sleep study as >10% of total sleep time with oxygen saturation of < 75%
- •Any condition determined by physicians that constrains the use of positive airway pressure such as anatomically fixed nasal obstruction, neurological impairment, and significant claustrophobia.
- •Congestive heart failure (New York Heart Association IV)
- •Severe valvular disease
- •Planned coronary revascularization procedure in the next 6 months
- •Severe pulmonary disease
- •Participation in another treatment intervention trial that might influence results of this trial
- •Ablation procedure scheduled in the next 8 weeks
结局指标
主要结局
Atrial Fibrillation recurrence
时间窗: 6 months after ablation
Risk of Atrial Fibrillation recurrence
次要结局
未报告次要终点
研究者
Clete A. Kushida
Professor
Stanford University