Evaluation of Safety and Feasibility of the Tioga TMVR System for Treatment of Mitral Regurgitation
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
- 5
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The study is aimed to assess the safety and feasibility of the Tioga TMVR System in treating patients with symptomatic MR (MR>=3+)
详细描述
The Tioga TMVR Feasibility Study is a prospective, single-arm, multi-center study with a planned enrollment of up to 30 patients. The Tioga TMVR System is designed to percutaneously replace a patient's diseased native mitral valve with a bioprosthetic valve. The investigational device is intended for transseptal replacement of the mitral valve in patients with symptomatic MR (MR>=3+).
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 or older
- •Symptomatic, moderate to severe (3+) or severe (4+) MR
- •NYHA Functional Classification ≥ II
- •Heart team concurs that the subject is non-ideal for surgical intervention or other available treatment options (e.g., TEER)
- •The subject or the subject's legal representative has been informed of the nature of the study, has agreed to return for post-procedure follow-up visits, and has provided informed consent
排除标准
- •LVEF < 30%
- •LVEDD > 70 mm
- •Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, MAC) unsuitable for the Tioga TMVR System
- •Severe aortic valve stenosis or regurgitation
- •Severe right ventricular dysfunction or severe tricuspid valve disease
- •Evidence of intracardiac thrombus, vegetation, or mass
- •Prior mitral valve intervention
- •Prior prosthetic heart valve in any position
- •Any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to enrollment
- •Any carotid surgery within 30 days prior to enrollment
- •Any open cardiac or vascular surgery (other than carotid surgery) within 90 days prior to enrolment
- •Myocardial infarction within 30 days prior to enrollment
- •Cardiac resynchronization therapy (CRT) device implanted within 30 days of enrollment
- •History of endocarditis within 6 months prior to enrollment or evidence of active systemic infection or sepsis.
- •Planned cardiovascular procedure within 30 days of enrolment
- •Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days of enrollment
- •Active peptic ulcer or active GI bleeding within 90 days of enrollment
- •Cardiogenic shock or hemodynamic instability requiring inotropic support or mechanical heart assistance
- •Pulmonary arterial hypertension with fixed PASP > 70mmHg or PVR > 5WU that cannot be reduced to less than 5WU with vasodilator therapy
- •Severe chronic obstructive pulmonary Disease (COPD) or airways disease requiring continuous home oxygen
- •Renal insufficiency (eGFR <20 mL/min) or ESRD on dialysis
- •Life expectancy < 12 months
- •Subject is on the waiting list for a transplant or has had a prior heart transplant
- •Child class C cirrhosis
- •Blood dycrasias as defined by acute anemia with Hb < 9, platelets < 75K, WBC < 0.5
- •Female subjects who is breast feeding or pregnant or planning to become pregnant within the study period.
- •Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution) or hypersensitivity to nickel or titanium
- •Inability to tolerate anticoagulation or antiplatelet therapies
结局指标
主要结局
Primary Safety Endpoint
时间窗: From index procedure (Day 0) to 30 days post-procedure
Number of subjects with all-cause mortality, cardiovascular-related hospitalizations, disabling stroke, and/or mitral valve reintervention or reoperation through 30 days post-procedure
Primary Performance Endpoint
时间窗: At completion of index procedure (Day 0)
Number of subjects achieving MVARC technical success - all of the following must be present at exit of catheterization lab: * Absence of procedural mortality * Successful access, delivery, and retrieval of the device delivery system * Successful deployment and correct positioning of the first intended device * Freedom from emergency surgery or reintervention related to the device or access procedure
次要结局
未报告次要终点