NCT03225612Unknown不适用
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 21
- 主要终点
- Incidence of all-cause mortality at 30 days.
研究概览
简要总结
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.
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. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 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, III, or ambulatory IV;
- •Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
- •patient is at high risk for open heart valve surgery
- •LVEF ≥35%
- •Tricuspid valve annular diameter ≤55 mm (or 29 mm/m^2)
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
结局指标
主要结局
Incidence of all-cause mortality at 30 days.
时间窗: 30-days
Incidence of all-cause mortality at 30 days.
次要结局
- Technical success(30 Days)
- Echocardiographic variable: tenting height (maximum, any view)(Change from Baseline at 30 days)
- Echocardiographic variable: tenting area (maximum, any view)(Change from Baseline at 30 days)
- Echocardiographic variable: Quantification of tricuspid valve and annular area (maximum, any view)(Change from Baseline at 30 days)
- Tricuspid regurgitation as determined by echocardiographic methods(Change from Baseline at 30 days)
- Percent tricuspid regurgitation from baseline to 30-days(Change from Baseline at 30 days)
- Adverse Events(Up to 60 months post procedure)
- New York Heart Association (NYHA) classification(Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure)
- Minnesota Living with Heart Failure Questionnaire (MLWHF)(Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure)
- Six-Minute Walk Test (6MWT)(Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure)
- EuroQol Five Dimensions Questionnaire (EQ-5D)(Change from Baseline at discharge and then 1, 3, 6, 12, 24, 36, 48 and 60 months post procedure)
研究者
研究点 (21)
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