HighLife™ Transcatheter Mitral Valve Replacement System for Severe Mitral Regurgitation in Patients at High Surgical Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 18
- 主要终点
- Technical success
研究概览
简要总结
Multicenter feasibility study of the HighLife™ TMVR system.
详细描述
This is an exploratory clinical study designed to evaluate the feasibility, safety and performance of the Highlife TMVR System in a population of patients with severe symptomatic mitral regurgitation, who are not suitable for surgical or approved percutaneous treatments according to the judgement of the Heart Team. The data gathered in this study will allow to evaluate the feasibility of mitral replacement using the HighLife™ TMVR system and characterize the safety and performance profile of the HighLife™ TMVR System.
All patients will be followed periodically up to 12 months after the intervention and long term safety and performance will be collected annually up to 5 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
- •Age ≥ 18 years
- •Severe mitral regurgitation
- •New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
- •Patient is under maximally tolerated GDMT (incl. CRT) for at least 3 months
- •Multidisciplinary Heart Team consensus that the patient is inoperable or at high-risk for surgical repair/replacement due to significant co-morbid conditions
- •Multidisciplinary Heart Team consensus that the patient is not a suitable candidate for other approved percutaneous repair therapy due to anatomical or medical conditions
- •Patient meets the anatomical criteria for HighLife valve sizing as determined by CT and TEE
排除标准
- •Mitral stenosis
- •Rheumatic valve disease
- •Severe calcifications of the mitral annulus and/or mitral leaflets
- •Prior surgical or interventional treatment of the mitral valve
- •Unsuitable anatomy for the transapical access
- •Unsuitable anatomy of the aorta and ilio-femoral vessels for the transfemoral access
- •Untreated clinically significant coronary artery disease requiring revascularization
- •LVEF < 30%
- •LVEDD > 70mm
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Hypertrophic Obstructive Cardiomyopathy (HOCM)
- •Any surgical or interventional procedure (including PCI) done in the past 30 days prior to procedure
结局指标
主要结局
Technical success
时间窗: immediately after procedure
defined as alive patient at exit from procedure room, with all of the following: * Successful access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife bioprosthesis * Freedom of additional emergency surgery or re-intervention related to the device or access procedure
Freedom of major adverse events
时间窗: at 30 days post procedure
including: * All-cause mortality * Myocardial infarction or coronary ischemia requiring PCI or CABG * Major stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for ≥ 48H
Continued intended performance of the HighLife™ bioprosthesis
时间窗: at 30 days post procedure
defined as the reduction of mitral regurgitation (MR) to either optimal (0+ to trace) or acceptable (reduced by at least 1 grade from baseline with no more than 2+ MR) without significant mitral stenosis (post-procedure EOA ≥ 1.5 cm2 with a transmitral gradient \< 5mmHg) and with no greater than mild (1+) paravalvular MR (and without associated hemolysis)
次要结局
- Device Success (per MVARC definitions)(At 30 days, 6 months and 12 months post procedure)
- Patient Success(At 30 days, 6 months and 12 months post procedure)
- Quality of Life Improvement vs. Baseline(At 6 months and 12 months)
- Procedure Success(At 30 days, 6 months and 12 months post procedure)
- Hemodynamic Performance vs. Baseline(At 7 days, 30 days, at 6 months and 12 months and at 2, 3, 4 and 5 years)
- Functional Improvement vs. Baseline(At 30 days, 6 months and 12 months)