A Prospective, Multi-center, Single-arm Clinical Investigation for Evaluation of the Safety and Effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Rate of device success-Phase I
研究概览
简要总结
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
详细描述
This is a prospective, multi-center, single-arm clinical investigation for evaluation of the safety and effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis. The investigation has two phases.
Phase I（FIM）：The FIM stage is a prospective, multicenter, single-arm observational clinical investigation, aiming to evaluate the feasibility and safety of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System. A total of 10 patients will be enrolled and 30-day clinical outcomes will be collected.
Phase II (Pivotal)：The pivotal stage is a prospective, multi-center, single-arm clinical investigation with the performance goal, aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 110 patients will be enrolled in 11 clinical centers across China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2 to 5 years annually post-procedure.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment was limited to patients who met all of the following criteria:
- •Age ≥ 70 years old(Phase II)/Age ≥18 years old,male or female who are not pregnant (Phase I);
- •Patients have severe aortic stenosis: Mean gradient> 40mmHg(1mmHg = 0.133kPa), or peak velocity> 4m/s, or an aortic valve area(AVA) <1.0 cm² (or AVA index <0.6 cm²/m²);
- •NYHA classification ≥ II;
- •Life expectancy> 12 months;
- •Anatomically suitable for transcatheter aortic valve implantation;
- •Assessed by a multidisciplinary heart team as a patient unsuitable for surgical aortic valve replacement;
- •Patients who can understand the purpose of the investigation, volunteer to participate in and sign the informed consent form, and are willing to comply with relevant examinations and follow-up visits.
排除标准
- •Acute myocardial infarction occurred within 30 days before the treatment;
- •Patients with congenital unicuspid aortic valve or aortic root anatomy and lesions that are not suitable for transcatheter valve implantation;
- •Any therapeutic heart surgery within 30 days;
- •Mixed aortic valve disease(aortic stenosis with severe regurgitation); moderate and severe mitral stenosis; severe mitral regurgitation; severe tricuspid regurgitation;
- •Blood dyscrasia, including neutropenia (WBC < 3 × 10^9/L), acute anemia(HB <90 g/L), thrombocytopenia(PLT <50 × 10^9/L), hemorrhagic constitution, and coagulopathy disease;
- •Untreated coronary artery disease requiring revascularization;
- •Hemodynamic instability requiring systolic support or mechanical heart assistance;
- •Need for emergency surgery for any reason;
- •Obstructive hypertrophic cardiomyopathy;
- •Severe left ventricular dysfunction, left ventricular ejection fraction(LVEF) < 20%; severe pulmonary hypertension and right ventricular dysfunction;
- •Echocardiography suggests the presence of intracardiac masses, thrombi, or neoplasms;
- •Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months;
- •Allergy to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or contrast agents;
- •Cerebrovascular events including transient ischemic attack(TIA) occurred within 6 months;
- •Renal insufficiency decompensation(end creatinine clearance < 20ml/min), and / or end-stage renal disease require long-term dialysis treatment;
- •Vascular diseases affecting device access;
- •Active infectious endocarditis or other active infection;
- •Participated in clinical investigations of other drugs or medical devices before the election, and had not completed the primary endpoint;
- •The investigator judged that the patient had poor compliance and could not complete the study as required.
结局指标
主要结局
Rate of device success-Phase I
时间窗: at immediate post-procedure
All-cause mortality at 12 months post implantation-Phase II
时间窗: at 12 months post-procedure
次要结局
- Heart function(NYHA)-Phase II(at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation)
- Rate of major adverse events -Phase I(at 30 days post implantation)
- Hemodynamic performance-Phase II(at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation)
- Rate of safety events according to VARC2-Phase II(at immediate, 30 days, 1 year and annually up to 5 years post implantation)
- Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II(at immediate, 30 days, 1 year and annually up to 5 years post implantation)
- Rate of balloon pre-dilatation success-Phase II(at immediate post implantation)
- Rate of balloon post-dilatation success-Phase II(at immediate post implantation)