NCT01873352已完成3 期
Evaluate Renal Artery Denervation In Addition to Catheter Ablation To Eliminate Atrial Fibrillation (ERADICATE--AF) Trial
Meshalkin Research Institute of Pathology of Circulation4 个研究点 分布在 3 个国家目标入组 302 人开始时间: 2013年6月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 4
- 主要终点
- AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds
研究概览
简要总结
The objective of this trial is to determine the role of renal sympathetic denervation in the prevention of atrial fibrillation (AF) recurrence in patients with hypertension for whom a catheter-based AF ablation procedure is planned. Patients will be randomized to either AF catheter ablation (usual therapy) or AF catheter ablation plus renal sympathetic 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
- Single (Participant)
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
- •Age ≥ 18 years of age
- •History of PAF and plans for a guideline-supported catheter ablation procedure. Paroxysmal AF is defined as AF with duration of 30 secs to 7 days.
- •History of significant hypertension (defined as SBP ≥130 mm Hg and/or DBP ≥80 mmHg) and receiving treatment with at least one anti-hypertensive medication
- •Renal vasculature accessible as determined by pre-procedural renal MRA
- •Willingness to comply with all post-procedural follow-up requirements and to sign informed consent
排除标准
- •Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus, contraindication to all anticoagulation)
- •Prior left atrial ablation for an atrial arrhythmia
- •NYHA class IV congestive heart failure
- •Pers or longstanding Pers AF (duration > 7 days)
- •Renal artery anatomy that is ineligible for treatment
- •An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation
- •Life expectancy <1 year for any medical condition
结局指标
主要结局
AAD-free freedom from AF/atrial flutter/atrial tachycardia recurrence at least 30 seconds
时间窗: 12 months
次要结局
- Blood pressure control between the two groups as compared to baseline(12 months)
- Major adverse cardiac events (defined as a composite of: death, stroke, CHF hospitalization, clinically diagnosed thromboembolic events other than stroke and hemorrhage requiring transfusion)(12 months)
- Total number of anti-hypertensive medications at study end, compared between the two treatment arms(12 months)
- Procedure adverse events(12 months)
- Freedom from AF recurrence (not-including the pre-defined 3 month blanking period) despite taking AADs(12 months)
- Differences in measures of LV hypertrophy/compliance (LV wall thickness, mitral inflow parameters) and LA size(12 months)
- Serious adverse events throughout follow-up(12 months)
研究者
研究点 (4)
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