TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.
- Conditions
- Tricuspid RegurgitationTricuspid Valve Disease
- Interventions
- Device: TricValve® Transcatheter Bicaval Valve SystemDrug: Optimal medical therapy
- Registration Number
- NCT06458907
- Lead Sponsor
- P+F Products + Features USA Inc.
- Brief Summary
The Investigational Device is the TricValve Transcatheter Bicaval Valve System (also referred to as the TricValve System).
The bioprosthesis is available in two different diameters for each model (SVC and IVC) specifically designed to adapt to the anatomic features of the superior vena cava (SVC) and inferior vena cava (IVC).
The SVC and IVC valves are single use, sterile devices provided in two sizes each, for a total of four valve sizes. The valves are designed for heterotopic caval implantation without perturbing the native tricuspid valve. The valves are made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.
The SVC and IVC valves are provided pre-mounted in two separate TricValve Delivery Systems, and are individually packaged into two separate boxes, provided sterile and ready to use. The two TricValve Delivery Systems deliver the two valves percutaneously into the SVC and IVC via femoral vein access using a transvenous approach.
- Detailed Description
This 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 TR and caval reflux (CR).
The TricValve System received Breakthrough Device Designation from the US FDA.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 600
- The subject must be 18 years or older.
- Severe tricuspid regurgitation (TR), as determined by Echo Core Lab.
- NYHA Class III-IVa or heart failure (HF) admission in the past 6 months.
- Subject is treated with stable OMT for at least 30 days.
- The local Heart Team and Independent Eligibility Committee (IEC) determine that the patient is eligible
- For females of childbearing potential, negative pregnancy test.
- Capable and willing to provide signed informed consent.
- Recent Myocardial Infarction (MI), stroke or Cerebrovascular Accident (CVA); major cardiovascular surgery within 90 days.
- Subject requires another planned major cardiac procedure.
- Left Ventricular Ejection Fraction (LVEF) ≤ 30% on echocardiography.
- Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
- Tricuspid stenosis.
- Severe right ventricular dysfunction.
- Cardiac amyloidosis.
- Pulmonary artery systolic pressure (PASP) >65 mmHg.
- 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
- 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.
- Life expectancy lower 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) ≤ 25 mL/min/1.73 m2 or dialysis.
- 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 TricValve procedure.
- Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, Right ventricular (RV) dysplasia, and arrhythmogenic RV.
- Participation in other investigational devices or drug 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TricValve® Device (Device) + Optimal medical therapy (OMT) Optimal medical therapy TricValve® Device (Device) + OMT TricValve® Device (Device) + Optimal medical therapy (OMT) TricValve® Transcatheter Bicaval Valve System TricValve® Device (Device) + OMT TricValve Single Arm Registry TricValve® Transcatheter Bicaval Valve System Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry. Optimal medical therapy (OMT) Alone Optimal medical therapy OMT can prevent heart attacks and heart failure with medications like blood thinners, cholesterol drugs, and blood pressure meds. TricValve Single Arm Registry Optimal medical therapy Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.
- Primary Outcome Measures
Name Time Method Tricuspid valve surgery or percutaneous tricuspid intervention 12 Months Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
Q-wave myocardial infarctions 1 Month Number of myocardial infarctions at 30 Days.
Major access-site, vascular, or cardiac structural complications 1 Month Number of days until death.
Six Minute Walking Test (6MWT) 6 Months, 12 Months Change in walking distance
Right Ventricular Assist Device (RVAD) implantation or heart transplant 12 Months Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant
Pulmonary embolism 1 Month Number of days until death.
Reduction in Caval Reflux (CR) 6 Months Reduction in CR, measured by echocardiography
Kansas City Cardiomyopathy Questionnaire (KCCQ Score) 6 Months, 12 Months Change in KCCQ score (score ranges between 0 and 100)
Mortality 1 Month, 12 Months Number of Cardiovascular Deaths at 30 Days.
Disabling stroke 1 Month Number of days until death.
Life threatening bleeding 1 Month Number of days until death.
Heart Failure Events 12 Months Number of heart failure episodes including hospitalization, or worsening heart failure
Renal failure requiring dialysis 1 Month Number of days until new renal replacement therapy.
Emergency surgery or intervention related to the device/procedure complications 1 Month Number of days until emergency surgery or intervention.
New York Heart Association (NYHA Class) 6 Months, 12 Months Change in NYHA class (range from I to IV)
- Secondary Outcome Measures
Name Time Method All-Cause mortality 3 Months, 6 Months, and 12 Months Number of days until death.
Atrial Fibrillation 3 Months, 6 Months, and 12 Months Days to new onset of atrial fibrillation.
Kansas City Cardiomyopathy Questionnaire (KCCQ Score) 3 Months, 6 Months, and 12 Months Change in KCCQ score (score ranges between 0 and 100)
Secondary Safety Endpoint (measured at 1 year) 12 Months The percentage of subjects with Device- and/or Procedure-related MAEs through 1 year.
Right Ventricular Assist Device (RVAD) implantation or heart transplant 3 Months, 6 Months, and 12 Months Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant.
Six Minute Walking Test (6MWT) 3 Months, 6 Months, and 12 Months Change in walking distance
Trial Locations
- Locations (15)
Scripps Memorial Hospital La Jolla
🇺🇸San Diego, California, United States
Northshore Evanston Hospital
🇺🇸Evanston, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
University of Texas (Memorial Hermann)
🇺🇸Houston, Texas, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Ascension Medical Group St. Vincent The Heart Center of Indiana
🇺🇸Indianapolis, Indiana, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
🇺🇸Irving, New York, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
UPMC Pinnacle
🇺🇸Harrisburg, Pennsylvania, United States
Houston Methodist
🇺🇸Houston, Texas, United States
Intermountain Heart Institute - Intermountain Medical Center
🇺🇸Murray, Utah, United States
MedStar Washington Hospital Center
🇺🇸Multiple Locations, Washington, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States