NCT00814840已完成2 期
Triple-Site Versus Standard Cardiac Resynchronization Therapy (TRUST CRT) Randomized Trial
Silesian Centre for Heart Diseases2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Combined end-point of alive status, freedom from hospitalization for HF or heart transplantation, relative ≥10% increase in LV ejection fraction, ≥10% in VO2max and ≥10% in 6MWD.
研究概览
简要总结
The purpose of this study is to assess the efficiency of permanent biventricular pacing using three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in cardiac capacity and patients' functional status in subjects with congestive heart failure and a physiologic (sinus) rhythm.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or more,
- •Congestive heart failure (HF) in NYHA class III-IV within last 90 days despite optimal medical treatment,
- •Left ventricular ejection fraction (EF) <=35% measured with echocardiography,
- •Sinus rhythm >90% of the time in 24-h Holter monitoring 1-3 days prior to randomization,
- •Inter- or intraventricular mechanical dyssynchrony ≥40ms measured with pulse Doppler and tissue Doppler echocardiography,
- •Optimal pharmacotherapy during the last 90 days,
- •Signed informed, written consent.
排除标准
- •Pregnancy or breastfeeding,
- •Unstable HF requiring hospitalization with intravenous inotropic drugs within last 90 days,
- •Myocardial infarction, percutaneous/surgical revascularization or any cardiosurgical procedure within 90 days prior to randomization,
- •Stroke within last 90 days,
- •History of chronic or persistent atrial fibrillation, flutter, tachycardia,
- •Acute myocarditis,
- •Implanted previously pacemaker, ICD or CRT-device,
- •Participation in a concurrent trial that could confuse the results of this study,
- •Mechanical right heart valve,
- •Prior heart transplant,
- •Valvular disease that is indication for valve surgery,
- •Coronary heart disease if percutaneous or surgical revascularization is indicated and possible,
- •Any state, apart from HF, that limits the estimated survival time to <1 year,
- •Unwillingness or inability to understand the nature of the study, to participate or to give written informed consent.
结局指标
主要结局
Combined end-point of alive status, freedom from hospitalization for HF or heart transplantation, relative ≥10% increase in LV ejection fraction, ≥10% in VO2max and ≥10% in 6MWD.
时间窗: six months
次要结局
- The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death).(five years)
研究者
Radoslaw Lenarczyk
Primary Investigator
Silesian Centre for Heart Diseases
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Trip HF Study: Triple Resynchronization in Paced Heeart Failure PatientsVentricular DyssynchronyHeart FailureNCT00187265Abbott Medical Devices
撤回
4 期
Biventricular Alternative PacingAtrioventricular BlockNCT00559143Medtronic Hellas Medical Devices ΑEE38
已完成
不适用
Heart Failure Study of Multi-site Pacing Effects on Ventriculoarterial CouplingHeart FailureNCT03189368National and Kapodistrian University of Athens80
已完成
不适用
A Comparison of Two Techniques for Choosing the Best Place to Put a Pacing Lead for Cardiac Resynchronisation TherapyHeart FailureNCT02061241Oxford University Hospitals NHS Trust22
已完成
不适用
Conduction System Pacing Versus Biventricular Resynchronization in Patients With Chronic Heart FailureLeft Bundle-Branch BlockCardiac ResynchronizationConduction System PacingHeart FailureNCT05572736Hospital Moinhos de Vento179