European Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System (AHEAD Study)
概览
- 阶段
- 不适用
- 干预措施
- Cardiovalve Transfemoral Mitral Valve
- 疾病 / 适应症
- Mitral Regurgitation
- 发起方
- Cardiovalve Ltd.
- 入组人数
- 30
- 试验地点
- 19
- 主要终点
- The primary safety endpoint is freedom from all-cause mortality and major adverse events
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
概览
简要总结
This study will evaluate the safety of the Cardiovalve Transfemoral Mitral Valve System with its associated procedure, and observe the device performance in reducing mitral regurgitation. Data collected in this clinical study will include 30-day safety and performance, and long-term clinical outcomes over a follow-up of 2 years.
详细描述
The Cardiovalve offers a mitral replacement valve delivered through a transfemoral access and transseptal approach, and is intended to reduce mortality and adverse event rates in selected patients for whom surgical options are not feasible. Innovation: A truly trans femoral, trans venous delivery of the prosthetic mitral valve which minimizes procedural risk. The Cardiovalve Implant features a dual nitinol frame for robust radial strength with decoupling of the atrial flange and ventricular portion which contains 24 grasping legs designed for atraumatic anchoring of the device to the native mitral annulus. Valve leaflets are made of bovine pericardium. The Cardiovalve implant has a very low left ventricle (LV) protrusion footprint thus reducing the risk of LV outflow tract obstruction and/or interference with the LV. The Cardiovalve delivery system (DS) is designed for transfemoral delivery of the Implant with transseptal access to the left atrium. The catheter assembly is used to center the implant relative to the native mitral valve plane and align it with the left ventricual apex-to-base axis. After valve implantation, the delivery system is withdrawn.
研究者
入排标准
入选标准
- •General Inclusion Criteria
- •Age ≥ 18 years
- •NYHA functional II, III or ambulatory IV
- •Severe mitral regurgitation (MR grade 3-4+)
- •Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
- •Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.
- •Able to undergo Transesophageal Echocardiography (TEE).
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
- •The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
- •Anatomical Inclusion Criteria
排除标准
- •Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
- •Acute myocardial infarction within the previous 30 days
- •Any prior heart valve surgery or transcatheter mitral intervention
- •Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
- •Rheumatic heart disease or endocarditis within the previous 3 months
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- •Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
- •Aortic or pulmonic valve disease requiring surgery
研究组 & 干预措施
Cardiovalve Transfemoral Mitral Valve
Mitral replacement valve delivered through a transfemoral access and transseptal approach
干预措施: Cardiovalve Transfemoral Mitral Valve
结局指标
主要结局
The primary safety endpoint is freedom from all-cause mortality and major adverse events
时间窗: 30 days, 3 Months, 6 Months, 12 Months, and 24 Months
Freedom from all-cause mortality, all cause hospitalization, major adverse cardiac events (MACE), major device- or procedure- related serious adverse events
次要结局
- Device Success(30 days, 3 Months, 6 Months, 12 Months, and 24 Months)
- Patient Success(30 days, 3 Months, 6 Months, 12 Months, and 24 Months)
- Technical success(Intraoperative, 30 Days)
- Device Success(Intraoperative)