An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- Continued intended performance of the HighLife™ bioprosthesis
研究概览
简要总结
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
详细描述
Protocol Title:
An Early Feasibility Study of the HighLife 28mm Transcatheter Trans-Septal Mitral Valve Replacement System
Protocol # HL-2019-01, ver. 5.0
Phase: United States Early Feasibility Study
Investigational Devices:
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
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)
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
次要结局
- Technical success(immediately after procedure)