Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 21
- 主要终点
- Technical success at 30-days
研究概览
简要总结
The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR).
The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.
详细描述
A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-years post implantation.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
- •≥18 and ≤85 years old;
- •NYHA II - IV;
- •Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
- •LVEF ≥35%
- •Tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2 (Superscript)) and ≤55 mm (or 29 mm/m2 (Superscript))
排除标准
- •Pregnant or lactating female;
- •Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
- •Previous tricuspid valve repair or replacement;
- •Severe coronary artery disease;
- •MI or known unstable angina within the 30-days prior to the index procedure;
- •Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;
- •Chronic oral steroid use (≥6 months);
- •Life expectancy of less than 12-months
研究组 & 干预措施
Open Label
Non-randomized, open label clinical study that intends to treat up to 30 subjects with the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) using standard of care techniques and services that are typically used for structural heart procedures.
干预措施: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) (Device)
结局指标
主要结局
Technical success at 30-days
时间窗: 30-days
Technical success is defined as freedom from death with: successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.
次要结局
- Secondary safety and performance endpoints mid-term and long-term(24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months)
- Number of participants with a change in Minnesota Living with Heart Failure (MLWHF) Questionnaire and 6-minute walk test (6MWT) as compared to pre-treatment questionnaire responses and pre-treatment total distance walked(24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months)