Pulmonary Artery Denervation to Treat Severe Obstructive Sleep Apnea: a Single-center, Prospective, First-in-man Study（PADN-OSA）
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- the change from baseline to month 6 in apnea-hypopnea index
研究概览
简要总结
This project is focused on the treatment of severe obstructive sleep apnea with pulmonary artery denervation (PADN). Although it has now been proved that continuous positive airway pressure (CPAP) is the primary treatment for obstructive sleep apnea, on the other hand, there is evidence that 25 to 50% of patients can not tolerate CPAP.
The investigators previously reported the safety and efficacy of pulmonary artery denervation (PADN) for treatment of pulmonary hypertension. Excessive sympathetic activation play an important role in the occurrence and development of OSA and cause cardiovascular events. It is worth evaluating the feasibility and tolerance of introducing PADN at the severe stage of obstructive sleep apnea. Therefore, the purpose of our study is to evaluate the safety and feasibility of PADN in the treatment of severe OSA.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apnea hypopnea index more than 30, not tolerated or refused continuous positive airway pressure;
排除标准
- •Acute coronary syndrome;
- •Pregnant;
- •Expected life less than 12 months;
研究组 & 干预措施
Sham procedure
Patients in the sham group will take sham procedure like PADN.
干预措施: Sham procedure (Procedure)
Pulmonary Arterial Denervation
Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.
干预措施: Pulmonary Arterial Denervation (Procedure)
结局指标
主要结局
the change from baseline to month 6 in apnea-hypopnea index
时间窗: Baseline and 6 months
次要结局
- the absolute change in Epworth Sleepiness Scale from baseline to follow-up(Baseline and 6 months)
研究者
Shaoliang Chen
Vice President
Nanjing First Hospital, Nanjing Medical University