Junctional AV Ablation in CRT-D Patients With Atrial Fibrillation (JAVA-CRT Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 21
- 主要终点
- Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)
研究概览
简要总结
Cardiac resynchronization therapy (CRT) is a demonstrably effective device intervention for patients with heart failure with reduced ejection fraction and specific indication. However, many patients with heart failure (HF) are unable to maintain sinus rhythm and approximately 30-36% of CRT patients are in atrial fibrillation (AF).
详细描述
This study is designed to evaluate if patients with AF indicated for CRT will have significant reduction in left ventricular end-systolic volume when randomized to atrioventricular junction (AVJ) ablation. In this study, subjects will be randomized to receive CRT-D or CRT-D with AVJ ablation. Randomization will be stratified by enrolling center (1:1 ratio).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Optimal pharmacologic therapy is defined by published guidelines from the American Heart Association and the American College of Cardiology
- •Initial implantation of CRT-D or prior implantation of CRT-D within one year
- •Ischemic or nonischemic cardiomyopathy
- •LVEF ≤ 35%
- •NYHA class II-IV (ambulatory)
- •QRS ≥ 120 ms for LBBB and ≥ 150 ms for non-LBBB patients
- •Continuous AF > 3 months when no further efforts to restore sinus rhythm are feasible or pursued
排除标准
- •Ventricular rate > 110 bpm at rest despite maximal medical therapy
- •Ventricular rate < 50 bpm at rest
- •Heart block/symptomatic bradycardia that necessitates permanent pacing
- •Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- •Severe aortic or mitral valvular heart disease
- •Prior AVJ ablation
- •Any medical condition likely to limit survival to < 1 year
- •Patients with ACC/AHA Stage D refractory Class IV symptoms listed for transplant or requiring inotropic support
- •Contraindication to systematic anticoagulation
- •Renal failure requiring dialysis
- •AF due to reversible cause e.g. hyperthyroid state
- •Pregnancy
- •Participation in other clinical trials that will affect the objectives of this study
- •History of non-compliance to medical therapy
- •Inability or unwillingness to provide informed consent
- •Patients with short-lived AF or those in sinus rhythm are ineligible
研究组 & 干预措施
CRT-D
Patients will be randomized at enrollment. Patients in this arm of the study will receive cardiac resynchronization therapy with defibrillator (CRT-D).
干预措施: Cardiac resynchronization therapy - defibrillator (Device)
CRT-D and AVJ Ablation
Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.
干预措施: Atrioventricular junctional (AVJ) ablation (Procedure)
CRT-D and AVJ Ablation
Patients in this arm of the study will receive CRT-D and undergo atrioventricular junctional (AVJ) ablation.
干预措施: Cardiac resynchronization therapy - defibrillator (Device)
结局指标
主要结局
Number of Patients With Reduction ≥ 15% in Left Ventricular End-systolic Volume (LVESV)
时间窗: Baseline to 6 months
Number of patients with reduction ≥ 15% in left ventricular end-systolic volume (LVESV) in each arm of the study.
次要结局
- Change in Left Ventricular Ejection Fraction (EF)(Baseline to 6 months)
研究者
Jonathan Steinberg
Professor of Medicine - Cardiology
University of Rochester