A Prospective, Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation - TRICAV-I Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 91
- 主要终点
- Mortality
研究概览
简要总结
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.
详细描述
This is a prospective multicenter clinical investigation designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery.
Patients who meet all of the study inclusion criteria, will be treated with the TricValve System. After the intervention, patients will be followed up closely for 12 months. Long term safety and efficacy data will be collected annually up to 5 years.
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
- •Subject must be 18 years or older, at the time of signing the informed consent.
- •Subjects has severe tricuspid regurgitation (TR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab.
- •NYHA Class III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
- •Subject is adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team for at least 30 days prior to the index procedure, including a diuretic.
- •The local Heart Team and IEC determine that the patient is eligible for the TricValve procedure.
- •For females of childbearing potential, negative pregnancy test.
- •Capable of giving signed informed consent.
排除标准
- •Subject had a recent MI, stroke or cardiovascular accident; underwent coronary artery bypass graft surgery, had a percutaneous coronary intervention or other major cardiovascular surgery within 90 days prior to TricValve implantation.
- •Subject requires another planned major cardiac procedure, including left-sided transcatheter intervention or surgery (e.g. severe aortic stenosis, severe mitral regurgitation), coronary artery bypass or PCI or pulmonary valve correction. Please note that if closure of an ASD, iatrogenic ASD or PFO is performed, TricValve implantation can be performed 30 days after the intervention. Additionally, TricValve implantation can be performed 30 days after any Electrophysiology procedure (pacemaker, ICD, etc.).
- •LVEF ≤ 30% on echocardiography.
- •Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- •Tricuspid stenosis. (Per TVARC, echo criteria: TVA at least 1.5 cm2 or TVAi at least 0.9 cm2/m2 [at least 0.75 if BMI >30 kg/m2], DVI <2.2, mean gradient <5mm Hg); reduction of total tricuspid regurgitation to optimal (≤ mild [1+]) or acceptable (≤ moderate [2+]).
- •Severe right ventricular dysfunction.
- •Cardiac amyloidosis
- •Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or right heart catheterization.
- •Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
- •Hemodynamically significant pericardial effusion.
- •Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure)
- •Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
- •Unable to tolerate anticoagulation/antiplatelet therapy
- •Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
- •Any known life-threatening condition with an estimated life span of at least 12 months.
- •Platelet count < 75,000/mm3
- •Child-Pugh Severity Class C (10-15 points).
- •Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73 m2 or requiring chronic renal replacement therapy at the time of enrollment.
- •Endocarditis or active/ongoing infection requiring antibiotics.
- •Unable to walk at least 60 meters in a 6minute walk test.
- •Known bleeding or clotting disorders or patient refuses blood transfusion.
- •Active gastrointestinal (GI) bleeding within 3 months of randomization.
- •Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
- •Use or participation in other investigational device or drug study in which patient has not reached a primary endpoint to treat cardiovascular conditions related to the outcomes of the current study.
- •Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.
- •Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up
- •Pregnant or breastfeeding subjects and those who plan pregnancy during the clinical investigation follow-up period.
研究组 & 干预措施
TricValve® Device (Device) Group
subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies, per physician discretion.
干预措施: TricValve® Transcatheter Bicaval Valve System (Device)
结局指标
主要结局
Mortality
时间窗: 1 Month and 12 Months
Number of days until death
Stroke
时间窗: 1 Month
Number of days until death
Pulmonary Embolism
时间窗: 1 Month
Number of days until death
Valve Academic Research Consortium (VARC) type 2-4 bleeding complication
时间窗: 1 Month
Number of days until death
Major vascular, access-related, or cardiac structural complication
时间窗: 1 Month
Number of days until death
Emergency surgery or intervention related to the device/procedure complications
时间窗: 1 Month
Number of days until emergency surgery or intervention
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
时间窗: 12 Months
Change in KCC score (score ranges between 0 and 100)
Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine ≥4.0mg/dL (≥354 μmol/L) with an acute increase of ≥ 0.5 mg/dL (≥44 μmol/L)
时间窗: 7 Days
Number of days from baseline until increase
Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy
时间窗: 1 Month
Number of days until new renal replacement therapy
Right Ventricular Assist Device (RVAD) implantation or heart transplant
时间窗: 12 Months
Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant
Tricuspid valve surgery or percutaneous tricuspid intervention
时间窗: 12 Months
Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
Heart Failure Events
时间窗: 12 Months
Number of heart failure episodes including hospitalization, or worsening heart failure
New York Heart Association (NYHA class)
时间窗: 12 Months
Change in NYHA class (range from I to IV)
Six Minute Walking Test (6MWT)
时间窗: 12 Months
Change in walking distance
次要结局
- Six Minute Walking Test (6MWT)(12 Months)
- Tricuspid valve surgery or percutaneous tricuspid intervention(12 Months)
- New York Heart Association (NYHA class)(12 Months)
- Technical success of device placement (at exit from procedure room)(Intraprocedural)
- Device success within 30 days after device placement(1 Month)
- Heart Failure hospitalization or worsening Heart Failure (HF) which encompasses treatment with IV diuretics in the office or Emergency Department treatment during a <24-hour time period(12 Months)
- Mortality(12 Months)
- RVAD implantation or heart transplant(12 Months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Score(12 Months)
- Procedural success (at 30 days)(1 Month)