VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- VDyne, Inc.
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- Composite of major adverse events (MAEs)
研究概览
简要总结
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
详细描述
The clinical trial is a prospective, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 old
- •Subject is willing and able to comply with all study evaluations and provide consent
- •Subject must agree not to participate in any other clinical trial for a period of one year following index procedure
- •New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory
- •At least severe symptomatic tricuspid regurgitation.
- •Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR
- •Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement
- •Functional and/or degenerative TR graded as at least severe
排除标准
- •Subject unable or unwilling to comply with study required testing and follow-up visits
- •Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study
- •Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure.
- •Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically
- •Life expectancy ≤12 months due to non-cardiac comorbidities
- •Current IV Drug user (must be free from drug abuse for ≥1 year)
- •Subject unable or unwilling to provide written, informed consent before study enrollment
- •Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System
- •Hypersensitivity to metals (such as nickel or titanium)
- •Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)
- •Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve
- •Known significant intracardiac shunt (e.g., septal defect).
- •Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure
- •Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids
- •Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility
- •Leukopenia, chronic anemia (Hgb < 9 g/dL), current thrombocytopenia (platelets <70/mcL), history of bleeding diathesis, or coagulopathy
- •Unwilling to receive blood products
- •Deep vein thrombosis and/or pulmonary embolism in the last 6-months
研究组 & 干预措施
Single Arm Registry
Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation who are deemed ineligible to be treated with Active Comparator EVOQUE device.
干预措施: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System (Device)
Randomized cohort VDyne TTVR
Transcatheter tricuspid valve replacement with VDyne System in patients with severe or greater tricuspid regurgitation.
干预措施: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System (Device)
Randomized cohort Edwards EVOQUE TTVR
Transcatheter tricuspid valve replacement with Edwards EVOQUE System in patients with severe or greater tricuspid regurgitation.
干预措施: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System (Device)
结局指标
主要结局
Composite of major adverse events (MAEs)
时间窗: 30 days post-procedure
Composite of major adverse events consist of the following: * Cardiovascular mortality * Stroke * Life-threatening bleeding * Major vascular complications * Major cardiac structural complications * Stage 2 or 3 acute kidney injury * Myocardial infarction or coronary ischemia * Device-related obstruction of forward flow * Device-related pulmonary embolism * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention
时间窗: 12 months post-procedure
All-cause mortality, heart failure hospitalization and non-elective tricuspid valve reintervention will be adjudicated by a Clinical Events Committee.
Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
时间窗: 12 months post procedure
The Quality of Life KCCQ questionnaire is a measure of health-related quality of life. It is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life related to Heart Failure. From 23-items, the Overall Summary Score (OSS) will be calculated. In the OSS, each of the 23 items are converted onto a 0 to 100 scale using this formula: (Raw score - Minimum Raw Score)/(Maximum Raw Score - Minimum Raw Score) \* 100. Then these are averaged across the 23 items. A score of 100 (the maximum score) would indicate maximum quality of life relating to heart failure and a score of 0 (scale minimum) would indicate the worst possible quality of life relating to heart failure, with higher scores generally indicating higher quality of life.
Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)
时间窗: 12 months post procedure
The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure by classifying patients in one of four categories based on their limitations during physical activity and in degree of shortness of breath and or angina pain. Class I is the least severe and Class IV is the most severe. The classes are: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
次要结局
- All-Cause Mortality(At 12 months and 24 months)
- RVAD implantation or heart transplant(At 12 months and 24 months)
- Tricuspid valve surgical or percutaneous intervention(At 12 months and 24 months)
- Heart failure hospitalizations(At 12 months and 24 months)
- Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(At 12 months and 24 months)
- Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)(12 months)
- Change in 6-Minute Walk Distance (6MWD)(At 12 months and 24 months)
- Change in Echocardiographic Tricuspid Regurgitation (TR) grade from baseline using TransEsophageal Echocardiogram (TEE)(At 6 months, 12 months and 24 months post-implant compared to baseline)
- Change in Echocardiographic Tricuspid Regurgitation (TR) grade from baseline using TransThoracic Echocardiogram (TTE)(At 6 months, 12 months and 24 months post-implant compared to baseline)