Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
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.
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.
LVEF ≤ 30% on echocardiography.
Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
Parallel
TricValve System
Device• Heterotopic Transcatheter Valve Replacement (TVR) with the TricValve System in conjunction with optimal medical therapy
Optimal medical therapy
DrugOptimal medical therapy
Randomized Cohort: Caval Reflux (CR) grade reduction
Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR are better.
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
Randomized Cohort: Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT)
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
Randomized Cohort: Percentage of Device- and/or Procedure-related MAEs
Rate of Major Adverse Events
Randomized Cohort: All-Cause mortality and Cardiovascular Mortality
Number of deaths from any cause as well as cardiovascular events
Randomized Cohort: Heart Failure Hospitalizations (HFH)
Number of Heart Failure Hospitalizations and worsening HF events without hospitilization
Randomized Cohort: RVAD Implantation or Heart Transplant
Number of patients requiring RVAD Implantation or Heart Transplant
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P+F Products + Features USA Inc.
Lead sponsor
Meditrial USA Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
