NCT05841615招募中不适用
Evaluation of the Safety and Efficacy of Pulmonary Vein Isolation (PVI) Combined With Renal Denervation (RDN) in Patients With Atrial Fibrillation (AF) and Hypertension (HTN)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Malignant end point event 2
研究概览
简要总结
The close relationship between the increase of sympathetic tension, AF, and HTN cannot be ignored. In addition, the significant failure rate of PVI (20-50%) in the treatment of AF makes it very necessary to explore the effect of RDN on AF. Therefore, this study aims to compare the effects and safety of PVI alone and PVI combined with RDN with AF combined with HTN, which will open a new chapter for PVI combined with RDN in the treatment of AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18<age<75years
- •clinic blood pressure≥140/90mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥135/85mmHg
- •Ecg diagnosis of atrial fibrillation ;
- •who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.
排除标准
- •pregnant women or lactating patients;
- •Patients who were unsuitable for ablation before surgery （unilateral or bilateral renal artery shape and structure were found： renal artery stenosis exceeding 50%, renal aneurysm, previous renal artery interventional surgery, renal artery malformation, renal artery diameter < 4mm or length of treatable segment < 20mm）
- •Patients who only have one kidney or have a history of kidney transplantation
- •Patients with a history of renal arterial intervention or renal denervation
- •identified secondary hypertension or Pseudo hypertension except for renal parenchymal hypertension;
- •malignant tumors or end-stage diseases;
- •Severe peripheral vascular disease, abdominal aortic aneurysm
- •whose left atrium is larger than 55mm
- •obvious bleeding tendency and blood system diseases;
- •Severe peripheral vascular disease, abdominal aortic aneurysm;
- •A history of the acute coronary syndrome within two weeks;
- •acute or severe systemic infection;
- •drug or alcohol dependence or refusal to sign informed consent.
- •Other conditions that are not suitable for PVI and RDN
结局指标
主要结局
Malignant end point event 2
时间窗: within 2 years post operation
cerebral hemorrhage
Malignant end point event 4
时间窗: within 2 years post operation
cardiovascular death
Malignant end point event 1
时间窗: within 2 years post operation
Fatal and nonfatal stroke
Malignant end point event 3
时间窗: within 2 years post operation
acute myocardial infarction
次要结局
- Complex end point event 1(within 2 years post operation)
- Complex end point event 2(within 2 years post operation)
- Complex end point event 3(within 2 years post operation)
- Complex end point event 5(within 2 years post operation)
- Complex end point event 4(within 2 years post operation)
- Complex end point event 10(within 2 years post operation)
- Complex end point event 7(within 2 years post operation)
- Complex end point event 6(within 2 years post operation)
- Complex end point event 8(within 2 years post operation)
- Complex end point event 9(within 2 years post operation)
研究者
Zhengrong Huang
Professor
The First Affiliated Hospital of Xiamen University
研究点 (1)
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