A Prospective, Multicenter, Randomized, Clinical Trial of the TricValve Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation (TR).
Overview
- Phase
- Not Applicable
- Intervention
- Optimal medical therapy
- Conditions
- Tricuspid Regurgitation
- Sponsor
- P+F Products + Features USA Inc.
- Enrollment
- 600
- Locations
- 15
- Primary Endpoint
- Six Minute Walking Test (6MWT)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Optimal medical therapy (OMT) Alone
OMT can prevent heart attacks and heart failure with medications like blood thinners, cholesterol drugs, and blood pressure meds.
Intervention: Optimal medical therapy
TricValve® Device (Device) + Optimal medical therapy (OMT)
TricValve® Device (Device) + OMT
Intervention: TricValve® Transcatheter Bicaval Valve System
TricValve® Device (Device) + Optimal medical therapy (OMT)
TricValve® Device (Device) + OMT
Intervention: Optimal medical therapy
TricValve Single Arm Registry
Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.
Intervention: TricValve® Transcatheter Bicaval Valve System
TricValve Single Arm Registry
Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.
Intervention: Optimal medical therapy
Outcomes
Primary Outcomes
Six Minute Walking Test (6MWT)
Time Frame: 6 Months, 12 Months
Change in walking distance
Tricuspid valve surgery or percutaneous tricuspid intervention
Time Frame: 12 Months
Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
Q-wave myocardial infarctions
Time Frame: 1 Month
Number of myocardial infarctions at 30 Days.
Major access-site, vascular, or cardiac structural complications
Time Frame: 1 Month
Number of days until death.
Right Ventricular Assist Device (RVAD) implantation or heart transplant
Time Frame: 12 Months
Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant
Pulmonary embolism
Time Frame: 1 Month
Number of days until death.
Reduction in Caval Reflux (CR)
Time Frame: 6 Months
Reduction in CR, measured by echocardiography
Kansas City Cardiomyopathy Questionnaire (KCCQ Score)
Time Frame: 6 Months, 12 Months
Change in KCCQ score (score ranges between 0 and 100)
Mortality
Time Frame: 1 Month, 12 Months
Number of Cardiovascular Deaths at 30 Days.
Disabling stroke
Time Frame: 1 Month
Number of days until death.
Life threatening bleeding
Time Frame: 1 Month
Number of days until death.
Heart Failure Events
Time Frame: 12 Months
Number of heart failure episodes including hospitalization, or worsening heart failure
Renal failure requiring dialysis
Time Frame: 1 Month
Number of days until new renal replacement therapy.
Emergency surgery or intervention related to the device/procedure complications
Time Frame: 1 Month
Number of days until emergency surgery or intervention.
New York Heart Association (NYHA Class)
Time Frame: 6 Months, 12 Months
Change in NYHA class (range from I to IV)
Secondary Outcomes
- 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)