A First-in-Human Investigational Testing Authorization Study Evaluating the Safety and Performance of the Vesalius Transcatheter Mitral Valve Repair System in Patients With Severe, Symptomatic Degenerative Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Safety - Number of Participants Experiencing All-Cause Mortality
研究概览
简要总结
This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation. The study will enroll patients who are at high or prohibitive risk for conventional surgical repair or replacement of the mitral valve. Participants will receive implantation of the Vesalius TMVr System and will be followed to assess clinical outcomes, device performance, and any adverse events.
详细描述
This first-in-human study is designed to evaluate the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with symptomatic, severe or moderate-to-severe degenerative mitral regurgitation who are at elevated surgical risk. The study will enroll up to five patients in Canada to assess procedural feasibility, technical performance, and short-term clinical outcomes following device implantation. Endpoints are based on Mitral Valve Academic Research Consortium (MVARC) definitions, including measures of procedural and device success, freedom from major adverse events, and technical achievement of device deployment. Safety, functional, and hemodynamic parameters will be monitored at predefined intervals, and follow-up will include assessment of valve function, adverse events, and device performance. This study will provide preliminary data to support the further development and evaluation of the Vesalius TMVr System.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14)
- •New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV)
- •Elevated risk for surgical mitral valve repair: Society of Thoracic Surgery (STS) predicted risk of mortality (PROM) of ≥6% as determined by the STS Risk Calculator for Surgical Repair of Primary Mitral Regurgitation [1], as well as patient operative risk assessment by the Heart Team
- •Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging
- •Willing to adhere to study follow-up schedule for up to 5 years
- •Written informed consent provided
排除标准
- •Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate)
- •LV ejection fraction < 30%
- •Active bacterial endocarditis within 60 days of planned index procedure
- •Dialysis-dependent renal insufficiency
- •Body Mass Index (BMI) ≥ 45 kg/m2
- •Previous valvular surgery
- •Previous atrial septal surgery
- •Previous endovascular structural procedure(s) and/or device(s) within 6 months
- •Severe mitral annular calcification (MAC) prohibiting device implantation
- •Severe annulus or leaflet calcification
- •Leaflet perforation
- •Contraindication to anticoagulation / antiplatelet therapy
- •Patients with sensitivity to nickel or contrast media
- •Concomitant severe tricuspid regurgitation
- •Absence of conventional medial and lateral papillary muscle groups
- •Femoral vein cannot accommodate a 29 F catheter
- •Contraindication to Transoesophageal echocardiography (TEE)
- •Life expectancy <1 year due to non-cardiac comorbidities.
- •Presence of other anatomic, comorbid conditions, or other medical conditions that could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results, in the opinion of the Heart Team
- •Participation in other clinical investigation
- •Pregnant or planning to become pregnant
研究组 & 干预措施
Vesalius TMVr System
Participants in this arm will undergo implantation with the Vesalius Transcatheter Mitral Valve Repair (TMVr) System according to the study protocol. All procedures will be performed by trained interventional cardiologists, and participants will be followed for safety, device performance, and clinical outcomes at predefined intervals.
干预措施: Transcatheter Mitral Valve Repair (Device)
结局指标
主要结局
Safety - Number of Participants Experiencing All-Cause Mortality
时间窗: 30 Days
Number of participants experiencing all-cause mortality post-implant, prior to discharge, and through the 30-day follow-up period.
Number of Participants Achieving Technical Success
时间窗: Measured at Day 0 (Procedure Exit)
Number of participants achieving successful delivery and positioning of the device, absence of procedural mortality, and freedom from emergency cardiovascular surgery or reintervention related to the device through procedure exit.
Number of participants Achieving Device Success
时间窗: 30 Days
Number of patients achieving successful deployment and correct anatomical positioning of the device, absence of procedural mortality or stroke, and freedom from unplanned surgical or interventional procedures related to the device through 30 days.
Vesalius TMVr System Safety
时间窗: 30 Days
Number of deaths from any cause occurring post-implant, at hospital discharge, and at 30 days.
Vesalius TMVr Technical Success
时间窗: Measured at Day 0 (Procedure Exit)
Successful deployment and correct positioning of the first intended device, absence of procedural mortality, and freedom from emergency surgery or reintervention at the end of the procedure.
Vesalius TMVr Device Success
时间窗: 30 Days
Proper placement and positioning of the device, absence of procedural mortality or stroke, freedom from unplanned surgery or intervention, and continued intended device safety and function.
次要结局
- Number of Participants by Mitral Regurgitation (MR) Severity Grade(30 Days)
- Number of Participants Experiencing Major Adverse Events (MAE)(30 Days)
- Mitral Regurgitation Severity(30 Days)
- Major Adverse Events (MAE)(30 Days)