NCT00187265已完成不适用
Triple Resynchronization in Paced Heart Failure Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Z-ratio
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single
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
- •NYHA class III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month.
- •The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent);
- •Permanent atrial fibrillation (AF);
- •Left ventricular ejection fraction (LVEF) ≤ 35%;
- •Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol;
- •Aortic pre-ejection delay at least equal to 140 ms.
排除标准
- •Indication for a cardiac defibrillator;
- •Having presented a myocardial infarct within the previous 3 months;
- •Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures;
- •Presenting chronic pulmonary insufficiency;
- •Patients whose congestive heart failure requires the use of an intravenous inotropic support;
- •Presenting a dysthyreosis;
- •Having a life expectancy of less than one year, for other reasons than the congestive heart failure;
- •Unable to be followed-up in the scope of the study for geographical reasons;
- •Having refused to give their consent;
- •Minors (age < 18 years) and pregnant women.
结局指标
主要结局
Z-ratio
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart FailureCongestive Heart FailureHeart DiseaseNCT00814840Silesian Centre for Heart Diseases100
已完成
不适用
Triple-site Biventricular Stimulation in the Optimization of CRTHeart FailureNCT02350842MicroPort CRM30
Unknown
4 期
Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) IndicationLeft Bundle-Branch BlockHeart FailureNCT01415024Schuechtermann-Klinik30
Unknown
不适用
Cardiac ResynchrOniSation Via Stimulation of the LEFT Bundle in AF Patients.Pacing-Induced CardiomyopathyNCT05162716Nicolas Clementy, MD, PhD50
已完成
不适用
TRI-V Heart Failure (HF) Implanted Cardioverter Defibrillator (ICD) StudyHeart FailureNCT00746135Abbott Medical Devices40