NCT01898910已完成2 期
Ganglionated Plexi Ablation vs Renal Denervation in Patients Undergoing Pulmonary Vein Isolation. A Randomized Comparison
Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Freedom of AF or other atrial arrhythmias
研究概览
简要总结
The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different strategies, PVI plus Renal Denervation (RD) versus PVI plus GP ablation, in patients with atrial fibrillation. Results were assessed after follow-up of at least 1 year with the use of an implanted monitoring device (IMD).
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
- 否
入选标准
- •Symptomatic drug-refractory AF (with history of failure of ≥ 2 class I or III antiarrhythmic drugs) in patients referred for catheter ablation of AF
- •PAF with ≥1 monthly episodes or PersAF in patients who had already undergone ≥3 electrical cardioversions. PAF was defined as episodes lasting less than 7 days with spontaneous termination. PersAF was defined as lasting more than 7 days before being terminated pharmacologically or by electrical cardioversion.
- •History of significant hypertension (defined as SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg), receiving treatment with at least one antihypertensive medication
- •A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula
排除标准
- •Previous atrial fibrillation ablation
- •Type 1 of diabetes mellitus
- •Structural heart disease
- •Secondary cause of atrial hypertension
- •Severe renal artery stenosis or renal arteries abnormalities
- •Previous operations on renal arteries
- •Pregnancy
- •Previous heart, kidney, liver, or lung transplantation
- •Unwillingness of participant
研究组 & 干预措施
PVI+renal denervation+OMT
Active Comparator
干预措施: PVI+renal denervation (Procedure)
PVI+renal denervation+OMT
Active Comparator
干预措施: Optimal medial therapy (OMT) (Drug)
PVI+GP ablation+OMT
Active Comparator
干预措施: PVI + GP ablation (Procedure)
PVI+GP ablation+OMT
Active Comparator
干预措施: Optimal medial therapy (OMT) (Drug)
结局指标
主要结局
Freedom of AF or other atrial arrhythmias
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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