NCT03339310已完成不适用
FIX-HF-5C2: Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System in Subjects With Moderate-to-Severe Heart Failure With Ejection Fraction Between 25% and 45%
Impulse Dynamics10 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2017年10月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
研究概览
简要总结
This is a multicenter, prospective, single-arm study of the Optimizer Smart System with 2-leads
详细描述
This is a multicenter, prospective, single-arm treatment only confirmatory study of the 2-lead configuration of the Optimizer Smart System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects who are 18 years of age or older
- •Subject is male or a non-pregnant female
- •Subjects who have a baseline ejection fraction greater than or equal to 25% and less than or equal to 45% by echocardiography determined by the echocardiography core laboratory.
- •Subjects who have been treated for heart failure for at least 90 days (including treatment with a β-blocker for at least 90 days unless the subject is intolerant) and are in New York Heart Association functional Class III and IV at the time of enrollment.
- •Subjects receiving appropriate, stable medical therapy during the 30 days prior to enrollment for treatment of heart failure according to guideline recommendations. For patients with EF≤35%, this regimen shall consist of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor blocker and β-blocker. Angiotensin receptor -neprilysin inhibitor (ARNI) may be substituted for ACE inhibitors or ARBs and Ivabradine may also be considered in subjects with a heart rate >70bpm. Stable is defined as no more than a 100% increase or 50% decrease in dose.
- •Subjects who, in the opinion of the Principal Investigator (based on the current guidelines for clinical practice), have a clinical indication for an implanted cardiac defibrillator (ICD, e.g., EF≤35%) and/or pacemaker, must have an existing device unless the patient refuses to undergo the implantation of such device for personal reasons.
- •Subjects who are willing and able to return for all follow-up visits.
排除标准
- •Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg. The qualifying CPX test must be deemed adequate.
- •Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.
- •Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days before enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
- •Subjects hospitalized for heart failure requiring acute treatment with intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before enrollment and baseline testing or subjects receiving any form of positive inotropic support within 30 days before enrollment, including continuous IV inotrope therapy.
- •Subjects having a PR interval greater than 375ms.
- •Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions) or who are unable to perform baseline stress testing.
- •Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.
- •Subjects who have a biventricular pacing system, an accepted indication for such a device, or a QRS width of 130ms or greater.
- •Subjects who have had a myocardial infarction within 90 days of enrollment.
- •Subjects who have mechanical tricuspid valve.
- •Subjects who have a prior heart transplant.
- •Subjects on dialysis.
- •Subjects who are participating in another experimental protocol.
- •Subjects who are unable to provide informed consent.
研究组 & 干预措施
Optimizer Smart System with 2-leads
Experimental
All eligible subjects will have the Optimizer Smart System implanted and receive cardiac contractility modulation therapy (CCM).
干预措施: Optimizer Smart System with 2-leads (Device)
结局指标
主要结局
Change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX).
时间窗: 24 weeks
Device efficacy will be assessed as change in exercise tolerance quantified by peak VO2 measured on cardiopulmonary exercise stress testing (CPX). Subjects on device under FIX-HF-5C2 protocol will be compared to subjects on control under FIX-HF-5C protocol with respect to peak V02 mean change at 24-weeks from baseline.
Optimizer-device and -procedure related complication rate
时间窗: 24 weeks
Subjects experiencing an Optimizer device- or procedure-related complication through the 24-week study period, as determined by an independent events committee.
次要结局
- Total CCM delivery comparing 2 and 3-lead device configurations(24 weeks)
研究者
研究点 (10)
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