A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 780
- 试验地点
- 46
- 主要终点
- Six Minute Walking Test (6MWT)
研究概览
简要总结
Pivotal trial to evaluate the safety and effectiveness of the P&F TricValve® Transcatheter Bicaval Valve System.
详细描述
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TricValve System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with severe tricuspid regurgitation and unsuitable for approved transcatheter therapies. Subjects will be followed at discharge, 1 month, 30 days, 3 months, 6 months 12 months, and annually up to 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
- 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
- •Eligibility Criteria for Randomized Cohort:
- •Inclusion Criteria:
- •Age between 18 years and 85 years old, at the time of signing the informed consent.
- •Severe tricuspid regurgitation (TR) and Caval Reflux (CR), as determined by the qualifying transthoracic echocardiogram (TTE) confirmed by an echocardiography Core Lab. TVARC criteria will be used for the definition of TR severity.
- •NYHA Class II-III-IVa (not on inotropes, IABP or LVAD) or heart failure (HF) admission in the past 6 months.
- •Adequately treated with optimal medical therapy (OMT) for heart failure per the local Heart Team at the time of TR assessment for eligibility (TTE). OMT includes stable oral diuretic medications.
- •High risk for open surgery and is appropriate for transcatheter tricuspid therapies according to the local heart team.
- •Patient is unsuitable for approved transcatheter therapies and is eligible for the TricValve procedure, based on review of screening/baseline data and imaging core lab measurements by Central Screening Committee.
- •For females of childbearing potential, negative pregnancy test.
- •Capable and willing to provide signed informed consent
排除标准
- •CONCOMITANT PROCEDURES
- •Patient 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.
- •Patient 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.
- •CARDIOVASCULAR CONDITIONS
- •LVEF ≤ 30% on echocardiography.
- •Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- •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 the TricValve procedure.
- •Hemodynamically significant pericardial effusion.
- •Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
- •Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/ AHA/ ESC/ EACTS Stage D heart failure).
- •Presence of significant congenital or acquired heart disease such as RV dysplasia, arrhythmogenic RV or other conditions that could interfere with the TricValve procedure.
- •ALLERGIES / INTOLERANCE
- •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
- •COMORBIDITIES
- •Any known life-threatening condition with an estimated life span of less than 12 months.
- •Platelet count < 75,000/mm3
- •Child-Pugh Severity Class C (10-15 points).
- •Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 30 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 100 meters in a 6-minute walk test.
- •Known bleeding or clotting disorders or patient refuses blood transfusion.
- •Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.
- •Prior Malignancy: this study excludes participants at material risk of near-term cancer-related morbidity/mortality that could confound 12-month outcomes. This study allows the inclusion of fully treated, remote malignancies with documented No Evidence of Disease (NED)" criteria
- •a. History of any malignancy within 5 years prior to randomization or any active malignancy, except: i. Adequately treated non-melanoma skin cancer (basal or squamous cell) with no evidence of disease, or ii. Carcinoma in situ (e.g., cervical, breast DCIS) treated with curative intent and no evidence of disease.
- •b. Participants with a prior malignancy diagnosed >5 years before randomization are eligible if they meet all of the "No Evidence of Disease (NED)" criteria as specified below: i. No signs/symptoms of cancer on history and physical exam per standard of care; ii. No radiologic evidence of disease on surveillance imaging if such imaging is routinely indicated for that tumor type (not protocol-mandated); iii. Tumor markers (if applicable for that cancer) not suggestive of recurrence (e.g., stable/undetectable within site's lab reference and oncologist's judgment); iv. No active anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy, radiotherapy) and none planned; v. Treating oncologist's attestation (or primary physician if oncology follow-up is complete) that the participant is disease-free and appropriate for participation.
- •GENERAL EXCLUSIONS
- •Use or participation in other investigational device or drug study in which the 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 the 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.
- •Eligibility Criteria for Single Arm Cohort:
- •Inclusion Criteria:
- •Age > 85 years.
- •NYHA Class III-IV, on intravenous inotropes, IABP or LVAD.
- •LVEF ≤ 30% on echocardiography.
- •Severe RV dysfunction.
- •Severe pulmonary hypertension (PH), defined as Pulmonary artery systolic pressure (PASP) >65 mmHg assessed with Echo Doppler and /or mean Pulmonary Artery Pressure (mPAP >35) by right heart catheterization.
- •Renal insufficiency: eGFR between 25 and 30 mL/min/ 1.73 m² or on chronic renal replacement therapy.
- •Patient unable to walk a minimum distance of 100 mt during 6 minute walk test.
- •Prior malignancy not meeting the requirements applied for the Randomized Cohort, specified in Exclusion Criterion #
- •Comorbidities precluding inclusion in the Randomized Cohort (exclusion criteria #15 to #24).
研究组 & 干预措施
TricValve System + Optimal medical therapy (OMT)
Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy (OMT) in patients with caval reflux and tricuspid regurgitation.
干预措施: Optimal medical therapy (Drug)
TricValve Single Arm Registry
Single-Arm Registry for Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with OMT in patients with caval reflux and tricuspid regurgitation who are not eligible for randomization
干预措施: TricValve System (Device)
TricValve Single Arm Registry
Single-Arm Registry for Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with OMT in patients with caval reflux and tricuspid regurgitation who are not eligible for randomization
干预措施: Optimal medical therapy (Drug)
Optimal medical therapy (OMT) Alone
OMT alone in patients with caval reflux and tricuspid regurgitation
干预措施: Optimal medical therapy (Drug)
TricValve System + Optimal medical therapy (OMT)
Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy (OMT) in patients with caval reflux and tricuspid regurgitation.
干预措施: TricValve System (Device)
结局指标
主要结局
Six Minute Walking Test (6MWT)
时间窗: 6 Months, 12 Months
Change in walking distance
Tricuspid valve surgery or percutaneous tricuspid intervention
时间窗: 12 Months
Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
Q-wave myocardial infarctions
时间窗: 1 Month
Number of myocardial infarctions at 30 Days.
Major access-site, vascular, or cardiac structural complications
时间窗: 1 Month
Number of days until death.
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
Pulmonary embolism
时间窗: 1 Month
Number of days until death.
Reduction in Caval Reflux (CR)
时间窗: 6 Months
Reduction in CR, measured by echocardiography
Kansas City Cardiomyopathy Questionnaire (KCCQ Score)
时间窗: 6 Months, 12 Months
Change in KCCQ score (score ranges between 0 and 100)
Mortality
时间窗: 1 Month, 12 Months
Number of Cardiovascular Deaths at 30 Days.
Disabling stroke
时间窗: 1 Month
Number of days until death.
Life threatening bleeding
时间窗: 1 Month
Number of days until death.
Heart Failure Events
时间窗: 12 Months
Number of heart failure episodes including hospitalization, or worsening heart failure
Renal failure requiring dialysis
时间窗: 1 Month
Number of days until new renal replacement therapy.
Emergency surgery or intervention related to the device/procedure complications
时间窗: 1 Month
Number of days until emergency surgery or intervention.
New York Heart Association (NYHA Class)
时间窗: 6 Months, 12 Months
Change in NYHA class (range from I to IV)
次要结局
- All-Cause mortality(3 Months, 6 Months, and 12 Months)
- Atrial Fibrillation(3 Months, 6 Months, and 12 Months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ Score)(3 Months, 6 Months, and 12 Months)
- Secondary Safety Endpoint (measured at 1 year)(12 Months)
- Right Ventricular Assist Device (RVAD) implantation or heart transplant(3 Months, 6 Months, and 12 Months)
- Six Minute Walking Test (6MWT)(3 Months, 6 Months, and 12 Months)