TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.
NCT Number: NCT06458907
Acronym: TRICAV-II
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Tricuspid Regurgitation|Tricuspid Valve Disease
Interventions: DEVICE: TricValve® Transcatheter Bicaval Valve System|DRUG: Optimal medical therapy
Sponsor: P+F Products + Features USA Inc.
Collaborators: Meditrial USA Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2030-01
Locations: St. Joseph's Hospital and Medical Center, Phoenix, Arizona, 85013, United States|Scripps Memorial Hospital La Jolla, San Diego, California, 92037, United States|Tampa General Hospital, Tampa, Florida, 33606, United States|Northshore Evanston Hospital, Evanston, Illinois, 60201, United States|Ascension Medical Group St. Vincent The Heart Center of Indiana, Indianapolis, Indiana, 46260, United States|Cardiovascular Institute of the South, Houma, Louisiana, 70360, United States|Minneapolis Heart Institute Foundation, Minneapolis, Minnesota, 55407, United States|Montefiore Medical Center, Bronx, New York, 10467, United States|Columbia University Medical Center/ NewYork Presbyterian Hospital, Irving, New York, 10032, United States|Cleveland Clinic, Cleveland, Ohio, 44106, United States|UPMC Pinnacle, Harrisburg, Pennsylvania, 17107, United States|Houston Methodist, Houston, Texas, 77030, United States|University of Texas (Memorial Hermann), Houston, Texas, 77030, United States|Intermountain Heart Institute - Intermountain Medical Center, Murray, Utah, 84107, United States|MedStar Washington Hospital Center, Multiple Locations, Washington, 20010, United States

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.

Primary Outcome Measures: Mortality, Number of Cardiovascular Deaths at 30 Days., 1 Month, 12 Months|Q-wave myocardial infarctions, Number of myocardial infarctions at 30 Days., 1 Month|Disabling stroke, Number of days until death., 1 Month|Life threatening bleeding, Number of days until death., 1 Month|Pulmonary embolism, Number of days until death., 1 Month|Renal failure requiring dialysis, Number of days until new renal replacement therapy., 1 Month|Major access-site, vascular, or cardiac structural complications, Number of days until death., 1 Month|Emergency surgery or intervention related to the device/procedure complications, Number of days until emergency surgery or intervention., 1 Month|Reduction in Caval Reflux (CR), Reduction in CR, measured by echocardiography, 6 Months|Kansas City Cardiomyopathy Questionnaire (KCCQ Score), Change in KCCQ score (score ranges between 0 and 100), 6 Months, 12 Months|New York Heart Association (NYHA Class), Change in NYHA class (range from I to IV), 6 Months, 12 Months|Six Minute Walking Test (6MWT), Change in walking distance, 6 Months, 12 Months|Right Ventricular Assist Device (RVAD) implantation or heart transplant, Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant, 12 Months|Tricuspid valve surgery or percutaneous tricuspid intervention, Number of days until tricuspid valve surgery or percutaneous tricuspid intervention, 12 Months|Heart Failure Events, Number of heart failure episodes including hospitalization, or worsening heart failure, 12 Months
Secondary Outcome Measures: Secondary Safety Endpoint (measured at 1 year), The percentage of subjects with Device- and/or Procedure-related MAEs through 1 year., 12 Months|All-Cause mortality, Number of days until death., 3 Months, 6 Months, and 12 Months|Kansas City Cardiomyopathy Questionnaire (KCCQ Score), Change in KCCQ score (score ranges between 0 and 100), 3 Months, 6 Months, and 12 Months|Right Ventricular Assist Device (RVAD) implantation or heart transplant, Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant., 3 Months, 6 Months, and 12 Months|Six Minute Walking Test (6MWT), Change in walking distance, 3 Months, 6 Months, and 12 Months|Atrial Fibrillation, Days to new onset of atrial fibrillation., 3 Months, 6 Months, and 12 Months