Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects With Heart Failure and Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 117
- 主要终点
- Device-related Complications (Primary Safety Objective)
研究概览
简要总结
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).
Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.
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
- •Individuals must meet all the following:
- •Patient is aged 18 years or older;
- •Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
- •Patient has HFrEF (LVEF ≤40%);
- •Patient is on GDMT for heart failure;
- •Patient has a Class I or Class II indication for an ICD
- •Patient has a reasonable expectation of meaningful survival of > 1 year;
- •Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
- •Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
- •Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
- •Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
- •Prior heart transplant or ventricular assist device;
- •Implanted mechanical tricuspid valve;
- •PR interval greater than 375ms or advanced AV block;
- •In situ S-ICD, pacemaker, or CRT device;
- •Indicated for CRT;
- •End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
- •Indicated for permanent bradyarrhythmia pacing;
- •Unstable angina pectoris within 30 days prior to study consent;
- •Pregnant or planning to become pregnant during the study;
- •Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
- •Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
研究组 & 干预措施
CCM-D Implant
The subject is implanted with the CCM-D device.
干预措施: OPTIMIZER® Integra CCM-D System (Treatment Arm) (Device)
结局指标
主要结局
Device-related Complications (Primary Safety Objective)
时间窗: Implant to 6 months
Evaluate device-related complications through 6-months (excluding lead-related complications).
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
时间窗: Implant
Evaluate the device effectiveness in converting induced VF at the time of implantation.
次要结局
- Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)(Implant to 6 months)