Assessment of the Carillon Mitral Contour System® in Treating Heart Failure With Functional Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 163
- 主要终点
- Primary Safety Objective - Freedom from Major Adverse Events
研究概览
简要总结
The objective of this prospective, randomized, double- blinded (patient and assessors), sham-controlled clinical trial is to assess the safety and efficacy of the CMCS in treating heart failure with functional regurgitation (FMR).
详细描述
A total of 300 subjects will be randomized at up to 100 investigational sites in the United States, Canada, and Europe. Subjects will be randomized into one of two study groups using a 1:1 (Intervention : Control) ratio.
Study subjects who are eligible for this clinical study will undergo a transthoracic echocardiographic examination prior to randomization to evaluate the inclusion criteria associated with the severity of mitral regurgitation. A coronary angiogram will be performed to evaluate the coronary artery anatomy and a venogram to assess the suitability of the coronary sinus/great cardiac vein (CS/GCV) for placement of the Carillon implant.
If the subject meets the anatomic requirements for the Carillon implant placement, the subject will be randomized. Subjects who meet all eligibility criteria will be randomized into one of two study groups (Intervention or Control).
Subjects randomized to the Intervention group will undergo the Carillon implant procedure.
Subjects randomized to the Control group will experience an index procedure similar to the Intervention group (without implant placement) to ensure they will not be able to deduce the group assignment based on the type of intervention or time associated with the procedure.
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
- Double (Participant, Outcomes Assessor)
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
- •Symptomatic heart failure with functional (secondary) mitral regurgitation of at least 1+ (mild) severity
- •NYHA II, III, or IV
- •Six Minute Walk distance ≥ 100 meters and ≤ 600 meters
- •Left Ventricular Ejection Fraction ≤ 50%
- •≥ 55 mm (women)
- •≥ 57 mm (men)
- •LVESD ≤ 75 mm
- •Corrected NT-proBNP > 1200 pg/ml measured within 60 days of randomization, and/or one or more heart failure hospitalizations within one year prior to consent or one or more outpatient visits for intensification of heart failure therapy within one year prior to consent.
- •Optimal Guideline directed heart failure medical therapy assessed by the Central Review Committee
- •Age ≥ 18 years old
- •Carillon implant can be sized and placed in accordance with the IFU
- •The subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent
排除标准
- •Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device
- •Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture)
- •Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement
- •Severe mitral annular calcification
- •Severe aortic stenosis
- •Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year
- •Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months or any other medical condition that, in the judgement of the Investigator or Central Review Committee, makes the patient a poor candidate for this study
- •An entire list of eligibility is available in the clinical investigational plan
研究组 & 干预措施
Intervention Group
Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
干预措施: Carillon Mitral Contour System (Device)
Intervention Group
Carillon Mitral Contour System and Guideline Directed Heart Failure Medication
干预措施: Guideline Directed Heart Failure Medication (Other)
Control Group
Guideline Directed Heart Failure Medication
干预措施: Guideline Directed Heart Failure Medication (Other)
结局指标
主要结局
Primary Safety Objective - Freedom from Major Adverse Events
时间窗: 12 months
Freedom from a composite of major adverse events (defined as Device Embolization, Vessel Erosion, Cardiac Perforation, and occurrence of cardiac surgery or percutaneous coronary intervention) in the Intervention group is greater than performance goal of 90%.
Primary Efficacy Objective 1 - Hierarchical Clinical Composite
时间窗: 24 months
To demonstrate that the CMCS (Intervention) group is superior to the Control group on the hierarchical composite endpoint of death, Cardiac transplantation or LVAD implantation, unplanned percutaneous or surgical mitral valve intervention, unplanned heart failure hospitalization, change in KCCQ overall summary score, and change in six-minute walk distance at 24 months (analyzed when the last subject completes 12 months of follow-up.)
次要结局
- Secondary Efficacy Objective 8 - Incidence of alternative therapy and all-cause mortality(12 months of follow-up, and any available data up to 24 months)
- Secondary Efficacy Objective 9 - Total number of HFH(12 months of follow-up, and any available data up to 24 months)
- Secondary Efficacy Objective 3 - Change in LV End-Systolic Volume(12 months)
- Secondary Efficacy Objective 4 - Change in 6 Minute Walk Distance(12 months)
- Secondary Efficacy Objective 5 - Change in KCCQ(12 months)
- Secondary Efficacy Objective 6 - Change in NYHA Classification(12 months)
- Secondary Efficacy Objective 7 - Percent days lost due to HFH or CV death(12 months of follow-up, and any available data up to 24 months)
- Secondary Safety Objective - Freedom from peri-procedural Major Adverse Events(30 days or hospital discharge date, whichever is longer)
- Secondary Efficacy Objective 1- Regurgitant Volume(12 months)
- Secondary Efficacy Objective 2 - Change in LV End-diastolic Volume(12 months)
- Secondary Efficacy Objective 3 - Change in NYHA(12 months)
- Secondary Efficacy Objective 4 - Hierarchical Clinical Composite(12 months)
- Secondary Efficacy Objective 5 - Heart Failure Hospitalizations(12 months of follow-up, and any available data up to 24 months)
- Exploratory Secondary Endpoint 1 - Change in Six-Minute Walk Distance(12 months)
- Exploratory Secondary Endpoint 2 - Change in KCCQ(12 months)
- Exploratory Secondary Endpoint 3 - Change in LV End-systolic Volume(12 months)
- Exploratory Secondary Endpoint 4 - days lost due to HFH and CV death(12 months of follow-up, and any available data up to 24 months)
- Exploratory Secondary Endpoint 5 - Alternative Therapies(12 months of follow-up, and any available data up to 24 months)