PARACHUTE China: Multi-center, Prospective, Single-arm Clinical Evaluation of the Safety and Efficacy of the Parachute Percutaneous Left Ventricle Partitioning System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Reduction of LVESVi
研究概览
简要总结
The design of this study is a multi-center, prospective, single-arm clinical trial to evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning system. The purpose of this trial is to use the Parachute percutaneous left ventricular partitioning system to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease and provide the data required to gain Chinese regulatory approval.
详细描述
CardioKinetix has developed a catheter-based treatment method that can be used for treating patients with heart failure due to ischemic heart disease (left ventricle enlargement after anterior wall myocardial infarction). This implant device, called the "Parachute," is a partitioning membrane placed inside the apex of an enlarged ventricle with motion abnormalities. The Parachute implant device can then isolate the dysfunctional apex region in the ventricle, reduce ventricular volume, and improve left ventricular diastolic compliance.
Patients approved for enrollment after screening by cardiac CT or MRI will be implanted with a Parachute implant device (the study device). Patients will receive all appropriate medical therapy (AAMT) approved by their physician.
The patient cohort will include patients with heart failure who have wall motion abnormalities due to previous myocardial infarction, left ventricular ejection fraction ≤40% and ≥15%, and NYHA class II - IV（non-hospitalized). A maximum of 30 patients will be enrolled at seven centers. Patients who have passed screening with transthoracic echocardiography (TTE) and cardiac CT or MRI will be enrolled in the trial.
After confirming that a patient meets the enrollment qualifications with cardiac CT or MRI evaluation, the patient will be enrolled in the trial and will be implanted with a Parachute device and treated with warfarin/aspirin anticoagulation therapy.
In the follow-up periods 3 months, 6 months, and 1 year after surgery, clinical evaluation, TTE testing, functional assessment, 6-minute walk test, and evaluation of adverse events will be done.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years ≤ 79 years
- •BMI < 40'
- •Left ventricle ejection fraction ≤40% and ≥15%
- •Previous transthoracic echocardiography showing LV MI structural heart dysfunction represented by LV wall motion abnormalities (WMA)
- •Appearance of ischemic heart failure symptoms (NYHA class II to "nonhospitalized" class IV) following anterior wall infarction and within the previous 60 days
- •Left ventricle must have the appropriate anatomical structures (size and shape); cardiac CT and left ventricular angiography are used to confirm that implanting an appropriate Parachute device is possible
- •Have received appropriate treatment according to ACC/AHA guidelines
- •Subject or his/her legal representative informed of the nature of the study and consented to participate in all the provisions of the trial, signed the EC-approved informed consent form, agreed to undergo the post-surgery treatment plan and follow-up requirements, and is able to complete the follow-up and required follow-up examinations.
排除标准
- •Significant ventricle wall motion abnormalities in addition to the anteroapical region
- •Valvular stenosis or regurgitation (tricuspid, aortic, or mitral valve) > 2+
- •Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •Requires long-term dialysis for end-stage renal disease or onset of sepsis or active endocarditis
- •Life expectancy at time of enrollment and hospitalization <1 year
- •Known allergies or contraindications to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast agents, that cannot be sufficiently treated with medication before surgery
- •Cardiogenic shock within 72 hours of screening
- •Pregnant or planning to become pregnant during the study period
- •Participated in a clinical trial of another drug or medical device within 30 days of screening
- •The researchers have determined that patient compliance is poor and that the person will be unable to complete the study in accordance with the requirements
结局指标
主要结局
Reduction of LVESVi
时间窗: 3 months
The primary outcome measure is comparison of reduction in left ventricle end systolic volume index（LVESVi) after 3 months with baseline LVESVi. Evaluation will be performed via transthoracic echocardiography (TTE) by an independent central ultrasound laboratory (Yale University Clinical Research).
次要结局
- Major Adverse Cardiac Events(3 months)
- Improvement in NYHA Class(3 months)
- Improvement in Quality of Life(3 months)
- Improvement in 6 minute walk test(3 months)
- Procedural Success(Day 0)