NCT05856461Unknown不适用
Pulmonary Artery Denervation+ Atrial Fibrillation Ablation vs Atrial Fibrillation Ablation Only in Patients With Atrial Fibrillation and Group 2 of Pulmonary Hypertension
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 2 个国家目标入组 116 人开始时间: 2023年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
研究概览
简要总结
The goal of the study is to compare efficacy and safety of the pulmonary artery denervation procedure combined with atrial fibrillation ablation versus atrial fibrillation ablation alone in patients with paroxysmal and persistent atrial fibrillation and group 2 of the pulmonary hypertension
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean pulmonary artery pressure > 25 mm Hg and pulmonary artery wedge pressure > 15 mm Hg by right heart catheterization
- •Paroxysmal or persistent atrial fibrillation
- •NYHA II-III
- •BNP > 105 pg/ml
- •Indications for catheter ablation of atrial fibrillation according guidelines
- •LVEF > 50%
排除标准
- •Group 1,3,4 of the pulmonary hypertension
- •Left atrium diameter > 6 cm
- •Planned open heart surgery procedure
- •Previous heart valve surgery
- •Severe aortic, pulmonary, tricuspid or mitral, valves regurgitation
- •Thrombus in the left heart chambers
结局指标
主要结局
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
时间窗: 12 months
Freedom from Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia 3 months after blanking period without antiarrhythmic drugs
次要结局
- Number of hospitalizations(12 months)
- Perioperative complications(30 days)
- Pulmonary vascular resistance(12 months)
- Pulmonary wedge pressure(12 months)
- Clinical adverse events(12 months)
- Mean pulmonary artery pressure(12 months)
- Systolic pulmonary artery pressure(12 months)
- 6-minutes walking distance(12 months)
- Atrial fibrillation burden(12 months)
- Brain natriuretic peptide(12 months)
研究者
研究点 (2)
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