NCT01959997Unknown2 期
Randomized Comparison of Redo Pulmonary Vein Isolation With vs. Without Renal Denervation for Recurrent Atrial Fibrillation After Initial Pulmonary Vein Isolation
Meshalkin Research Institute of Pathology of Circulation3 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The absence of AF
研究概览
简要总结
The objective of this study is to compare the elimination of atrial fibrillation in patients with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when undergoing repeat PVI (control) vs repeat PVI plus renal denervation.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior PVI ablation procedure for paroxysmal AF within past 2 years
- •Recurrent symptomatic paroxysmal AF despite prior PVI
- •History of essential hypertension requiring at least 2 chronic antihypertensive medications
排除标准
- •Persistent AF after prior ablation
- •Congestive heart failure (NYHA III-IV functional class)
- •Left ventricle ejection fraction < 35%
- •Left atrial diameter >55 mm
- •An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
- •Renal arteries unsuitable for RDN:
- •Inability to access renal vasculature
- •Main renal arteries < 4 mm in diameter or < 20 mm in length.
- •Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
- •A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
- •Multiple main renal arteries to either kidney
- •Unwillingness to participate
结局指标
主要结局
The absence of AF
时间窗: 1 year
The absence of AF at one year as assessed by prolonged ambulatory ECG monitoring post-ablation after 3 month blanking period has expired following the repeat ablation procedure.
次要结局
- Systolic and diastolic blood pressures(1 year)
- procedural duration and complications(1 year)
- LV mass on echocardiogram(1 year)
研究者
研究点 (3)
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