NL-OMON42472尚未招募不适用
Cardiac Contractility Modulation (CCM) Therapy in Subjects with Medically Refractory Heart Failure: A Randomized Efficacy Study (*IMPULSE-HF*) - IMPULSE-HF
Impulse Dynamics Inc.0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •a) Baseline ejection fraction * 25% and *45% (as assessed by the site)
- •b) NYHA class II or III despite receiving optimal medical therapy for heart failure, stable for at least 30 days based on patient*s medical records (chronic, not transient, heart failure)
- •c) Baseline VO2,max * 9 and * 18.5 ml O2/Kg/min
排除标准
- •a) Potentially correctible cause of HF (valvular, congenital, or untreated ischemic heart disease)
- •b) Clinically significant angina pectoris
- •c) Hospitalization for HF requiring the use of inotropic support within 30 days of enrollment
- •d) PR interval greater than 375 ms
- •e) Permanent or long-standing persistent atrial fibrillation/flutter, or cardioversion within 30 days of enrollment.
- •f) Exercise tolerance limited by condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or unable to perform baseline stress testing
- •g) Scheduled for a CABG or a PTCA procedure, or CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
- •h) Biventricular pacing system, or indication for Biventricular pacing system
- •i) Myocardial infarction within 90 days of enrollment.
- •j) Mechanical tricuspid or aortic valves.
- •k) Ventricular assist device
- •l) Prior heart transplant
- •m) Pregnant or planning to become pregnant during the study
- •n) Age below 18
- •o) Subject participating in another study, unrelated to CCM, at the same time (or within 30 days prior to enrollment to this study)
- •p) Subjects on dialysis
研究者
相似试验
终止
不适用
Cardiac Contractility Modulation (CCM) Therapy in Subjects With Medically Refractory Heart FailureHeart FailureNCT02857309Impulse Dynamics50
已完成
不适用
Effects of CCM-therapy in Patients With Heart FailureHeart FailureNCT02895048Stiftung Institut fuer Herzinfarktforschung184
已完成
不适用
CCM in Heart Failure With Preserved Ejection FractionHeart Failure, DiastolicNCT03240237Impulse Dynamics47
招募中
不适用
CCM and Implementation of Guideline-Directed Medical Therapy in Patients With Heart Failure (Fix-GDMT-HF)Heart FailureNCT06580392Impulse Dynamics200
Unknown
不适用
Cardiac Contractility Modulation Therapy in Amyloid Cardiomyopathy Patients With Heart FailureAmyloidosis CardiacHeart FailureNCT05167799Ospedale C & G Mazzoni25