The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Rate of Technical Success
研究概览
简要总结
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants must fulfill all following inclusion criteria in order to be included in the post market registry:
- •Participant is indicated for the HighLife TSMVR system per the current approved Instructions For Use (IFU)
- •Participant (≥ 18 years age) with severe or moderately severe mitral valve regurgitation (MR) due to primary (i.e. degenerative) and/or secondary (i.e. functional MR.
- •Left Ventricular Ejection Fraction (LVEF) ≥ 30%
- •Left ventricular end-diastolic dimension (LVEDD) ≤ 70 mm
- •Based on the assessment of the local multidisciplinary heart team, the participant is:
- •unsuitable for heart surgery (mitral valve repair or replacement)
- •unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy)
- •eligible to receive the HighLife TSMVR system per the current approved Instructions For Use (IFU) and as assessed by the local heart team
排除标准
- •Participants will be excluded from the post market registry as per the current approved Instructions For Use (IFU) if any of the following criteria is met:
- •Significantly calcified mitral valves;
- •Severe mitral annular calcification
- •Narrow femoral arteries that don't allow the passage of 18F sheaths;
- •More than 80 cm between the aortic valve and the femoral access;
- •Allergies to TSMV or SAI components (bovine tissue, Nitinol, polyester, polyethylene, PTFE);
- •Intolerance to anticoagulation/antiplatelet regimens or procedural anticoagulation;
- •Active bacterial endocarditis or other active infections;
- •Allergies to contrast media;
- •Previous implanted aortic valve prosthesis;
- •Evidence of intracardiac mass, thrombus, or vegetation.
- •Participant enrolled in another clinical study that may impact the follow-up or results of this study.
- •Participant has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the patient's ability to participate in the clinical study or to comply with follow-up requirements.
- •Tricuspid valve disease requiring intervention
研究组 & 干预措施
Commercial patients
That meet the criteria as outlined in the IFU, and who are scheduled to have the HighLife procedure
结局指标
主要结局
Rate of Technical Success
时间窗: At exit from procedure room
To measure the rate of subjects that meet the definition of Technical success defined as an alive participant at exit from procedure room, with all of the following: * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm bio-prosthesis * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure
Rate of Device Success
时间窗: 30 days
To measure the rate of subjects that meet the definition of Device safety, defined as the freedom of major adverse events at 30 days, as follows: * All-cause mortality * Myocardial infarction * Major/disabling stroke * Life-threatening bleeding (MVARC scale) * Major access and vascular complications * Stage 2 or 3 acute kidney injury (includes dialysis) * Any mitral valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention * Severe hypotension, heart failure or respiratory failure requiring intravenous vasopressors 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 for ≥ 48 hours, or prolonged intubation for ≥ 48 hours
Primary Performance Endpoint
时间窗: 30 days
Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab
次要结局
- Total reduction of mitral regurgitation (MR) to 1+ or less(30 days, 6 months, 1, 2, 3 years)
- Reoperation(30 days)
- Disabling stroke(30 days, 6 months, 1, 2, 3 years)
- New onset conduction disturbance in the heart(30 days)
- Heart Failure Hospitalization(30 days, 6 and 12 months, 1, 2, 3 years)
- Freedom from left ventricular outflow tract obstruction (LVOTO)(30 days)
- Freedom from paravalvular leak (PVL), > 1+(30 days)
- Annualized rate of Heart Failure Hospitalization (HFH)(1, 2, 3 years)
- Procedural Mortality(At exit from the procedure room)
- All-cause mortality(30 days, 6 months, 12 months, 1, 2, and 3 year)
- Long term durability of the HighLife valve(3 years)
- KCCQ score (mean) improvement(1 year)
- Improvement in six minute walk test (6MWT)(1 year)