Safety Procedure Pulmonary Artery Denervation in Addition to Pulmonary Vein Isolation Combined With Ganglionated Plexi Ablation in Patients With Persistent Atrial Fibrillation and Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Perioperative Complications
研究概览
简要总结
Some patients with a long history of AF develops PH "reactive" type with an increase in pulmonary vascular resistance due to vasoconstriction or structural changes of the vascular wall. RFA PVI + RFA GP is the "gold standard" in the treatment of patients with persistent AF, do not respond to optimal therapy. The rear area of the pulmonary artery bifurcation is adjacent to the roof and part of the front of the left atrium. In the projection of this area are ganglionic plexus of the left atrium, the sympathetic nerve fibers of the pulmonary artery and baroreceptors main pulmonary artery.Recent studies have shown that radiofrequency denervation of the pulmonary artery improves the quality of life in patients with PH.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with symptomatic, drug - refractory AF ( inefficiency 1C or III Class antiarrhythmic drugs), history of AF 6 months or more without the restoration of sinus rhythm.
- •MPAP ≥25 mmHg
- •PCWP≥15 mmHg
- •Pulmonary vascular resistance (PVR). The PVR =(mPAP-PCWP)/ carbon monoxide] > 2.5 woods unit
排除标准
- •Left ventricular ejection fraction <35%
- •Diameter LA> 60 mm on transthoracic echocardiography in the "M" -Mode or volume of LA more than 140 ml
- •Significant regurgitation at the mitral valve
- •Uncorrected congenital heart disease
- •RFA PVI, RFA GP, PADN in history
- •Foregoing heart surgery
- •Life expectancy less than 12 months
- •WHO group I, III, IV, V pulmonary artery hypertension
- •Tricuspid valve stenosis, pulmonary supravalve stenosis.
- •Pregnancy
- •Thromboembolism LA history
- •Hyperthyroidism.
研究组 & 干预措施
PV isolation + GP Ablation
干预措施: PV isolation + GP Ablation (Procedure)
PV isolation + GP ablation + Pulmonary GP ablation
干预措施: PV isolation + GP ablation + Pulmonary GP ablation (Procedure)
结局指标
主要结局
Perioperative Complications
时间窗: 6 months
perforation / dissection at any level, an acute thrombosis in the pulmonary artery, re - hospitalization due to Pulmonary Hypertension, Atrial Fibrillation) immediately after and at 1, 3, 6 months after procedure
death
时间窗: 6 months
all-cause death at 1, 3, 6 months after procedure
次要结局
- recurrence of AF / AFL / AT(6 months)
- Quality of life(6 months)
- Mean Pulmonary Artery Pressure(6 months)
- 6-minute walk distance(6 months)
- Pulmonary vascular resistance(1 month)
- Assessment of respiratory function(6 months)