Capstan Medical TMVR Study: First-in-Human Evaluation of the Capstan TMVR System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 5
- 主要终点
- Incidence of procedural success
研究概览
简要总结
This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 at the time of consent.
- •Moderate-severe (3+) or severe (4+) mitral regurgitation
- •NYHA II or greater symptoms despite optimal medical treatment.
- •The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).
- •Ability and willingness to provide written informed consent prior to any study related procedure(s).
排除标准
- •LVEF less than 20%
- •Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System
- •Severe aortic valve stenosis or regurgitation
- •Severe mitral stenosis
- •Severe right ventricular dysfunction or severe tricuspid valve disease
- •Evidence of intracardiac thrombus, vegetation, or mass
- •Prior mitral valve intervention that would interfere with the appropriate placement of the Capstan Valve
- •Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to procedure
- •Myocardial infarction within 30 days prior to procedure
- •Cardiac resynchronization therapy (CRT) device implanted within 30 days of procedure
- •Active endocarditis, other ongoing infection requiring antibiotic therapy
- •Stroke or transient ischemic attack (TIA) within 30 days of procedure
- •Active peptic ulcer or active gastrointestinal bleeding
- •Severe pulmonary arterial hypertension with fixed PASP greater than 85mmHg
- •End-stage renal failure on dialysis
- •Life expectancy less than 1 year
- •Subject is on the waiting list for a heart transplant or has had a prior heart transplant
- •Pregnant (Participants of childbearing age are required to have a negative pregnancy test).
- •Known allergy to antiplatelet therapy, heparin, or to device materials
- •Inability to tolerate anticoagulation or antiplatelet therapies
- •Absence of appropriate venous access
- •Unable to have transesophageal echocardiography
- •Unwillingness to complete the required follow-up visits
研究组 & 干预措施
Implant
Participants who pass all screening criteria will undergo a percutaneous procedure for the implantation of a permanent mitral valve replacement device.
Participants will be followed for 5 years to evaluate safety and feasibility of Capstan Medical TMVR System for mitral valve replacement in humans with predominantly regurgitant mitral valves who are symptomatic and who are not good surgical candidates.
干预措施: Capstan System transcatheter mitral valve replacement (Device)
结局指标
主要结局
Incidence of procedural success
时间窗: Procedure through 30 days
Number of participants with successful valve deployment and freedom from death or re-hospitalization for heart failure at 30 days.
次要结局
- Freedom from MAE(30-days, 90-days, 6-months, 1-year, then annually to 5-years)
- Technical Success(30-Days)