A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation
概览
- 阶段
- 不适用
- 干预措施
- Optimal Medical Therapy
- 疾病 / 适应症
- Tricuspid Regurgitation
- 发起方
- Edwards Lifesciences
- 入组人数
- 870
- 试验地点
- 144
- 主要终点
- Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)
- 状态
- 招募中
- 最后更新
- 26天前
概览
简要总结
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
详细描述
A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.
研究者
入排标准
入选标准
- •Eighteen (18) years of age or older
- •Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
- •Severe or greater tricuspid regurgitation
- •New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
- •Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
- •Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
排除标准
- •Tricuspid valve anatomy not evaluable by TTE or TEE
- •Tricuspid valve anatomy precludes proper device deployment and function
- •Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)
- •Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:
- •Would prevent proper TR reduction due to interaction of the lead with the leaflets
- •Were implanted in the RV within the last 90 days prior to the point of enrollment
- •Primary non-degenerative tricuspid disease
- •Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
- •Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
- •Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment
研究组 & 干预措施
Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
干预措施: Optimal Medical Therapy
Edwards PASCAL System & OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
干预措施: Edwards PASCAL System
Single-Arm Registry
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
干预措施: Edwards PASCAL System
Continued Access Study
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
干预措施: Edwards PASCAL System
结局指标
主要结局
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)
时间窗: 6 months
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score)
时间窗: 12 months
Comparison of number of participants with composite endpoint events between experimental and active comparator arms
次要结局
- All-cause Mortality, TV Surgery or TV Interventions(24 months)
- All-cause Hospitalizations(12 months)
- 1 Grade Reduction in TR Severity(6, 12 months)
- Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)(3, 6, and 12 months)
- All Cause Mortality(12 months, 24 months)
- Death and Heart Failure Hospitalizations(12 months)
- All-cause Hospitalization(12 months)
- Right ventricular end-diastolic diameter (RVEDD mid)(12 months)
- Major Adverse Events (MAEs)(30 days)
- Reduction in TR grade(Intraprocedural post-implantation)
- All-Cause Mortality(12 months, annually through 5 years)
- Heart failure hospitalizations(12 months, annually through 5 years)
- Non-elective tricuspid valve re-intervenitions (percutaneous or surgical)(12 months, annually through 5 years)
- Durable RVAD implantation or heart transplant(12 months, annually through 5 years)
- Need for paracentesis(12 months, annually through 5 years)
- All cause mortality or the first heart failure hospitalization for patients with massive or torrential TR at baseline(12, 24 months)