Clinical trial NCT06458907: TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.
Official title: A Prospective, Multicenter, Randomized, Clinical Trial of the TricValve Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation (TR).
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Tricuspid Valve Disease
Keywords: Tricuspid Regurgitation
Heart Failure
Lead sponsor: P+F Products + Features USA Inc.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial USA Inc.
First posted: 2024-06-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. The subject must be 18 years or older.
2. Severe tricuspid regurgitation (TR), as determined by Echo Core Lab.
3. NYHA Class III-IVa or heart failure (HF) admission in the past 6 months.
4. Subject is treated with stable OMT for at least 30 days.
5. The local Heart Team and Independent Eligibility Committee (IEC) determine that the patient is eligible
6. For females of childbearing potential, negative pregnancy test.
7. Capable and willing to provide signed informed consent.

Exclusion Criteria:

1. Recent Myocardial Infarction (MI), stroke or Cerebrovascular Accident (CVA); major cardiovascular surgery within 90 days.
2. Subject requires another planned major cardiac procedure.
3. Left Ventricular Ejection Fraction (LVEF) ≤ 30% on echocardiography.
4. Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
5. Tricuspid stenosis.
6. Severe right ventricular dysfunction.
7. Cardiac amyloidosis.
8. Pulmonary artery systolic pressure (PASP) \>65 mmHg.
9. Lower extremity venous thrombosis and/or the presence of an IVC filter at the time of or 6 months prior to TricValve procedure.
10. Hemodynamically significant pericardial effusion.
11. Patient with refractory heart failure requiring advanced intervention
12. Any known allergy or hypersensitivity to nitinol, bovine tissue or contrast media that cannot be adequately treated with pre-medication.
13. Unable to tolerate anticoagulation/antiplatelet therapy.
14. Hemodynamic instability, cardiogenic shock, inotropic support, intra-aortic balloon pump or acute heart failure within 30 days prior to the TricValve procedure.
15. Life expectancy lower than 12 months.
16. Platelet count \< 75,000/mm3.
17. Child-Pugh Severity Class C (10-15 points).
18. Severe renal insufficiency with Estimated Glomerular Filtration Rate (eGFR) ≤ 25 mL/min/1.73 m2 or dialysis.
19. Endocarditis or active/ongoing infection requiring antibiotics.
20. Unable to walk at least 60 meters in a 6minute walk test.
21. Known bleeding or clotting disorders or patient refuses blood transfusion.
22. Active gastrointestinal (GI) bleeding within 3 months of TricValve procedure.
23. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, Right ventricular (RV) dysplasia, and arrhythmogenic RV.
24. Participation in other investigational devices or drug study.
25. Any other condition that would preclude ability to meet study requirements in the opinion of the investigator.
26. Psychiatric/behavioral issues or other medical or social conditions that preclude valid consent and follow-up.
27. Pregnant or breastfeeding subjects.

Primary outcomes:
measure: Mortality
timeFrame: 1 Month, 12 Months
measure: Q-wave myocardial infarctions
timeFrame: 1 Month
measure: Disabling stroke
timeFrame: 1 Month
measure: Life threatening bleeding
timeFrame: 1 Month
measure: Pulmonary embolism
timeFrame: 1 Month
measure: Renal failure requiring dialysis
timeFrame: 1 Month
measure: Major access-site, vascular, or cardiac structural complications
timeFrame: 1 Month
measure: Emergency surgery or intervention related to the device/procedure complications
timeFrame: 1 Month
measure: Reduction in Caval Reflux (CR)
timeFrame: 6 Months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ Score)
timeFrame: 6 Months, 12 Months
measure: New York Heart Association (NYHA Class)
timeFrame: 6 Months, 12 Months
measure: Six Minute Walking Test (6MWT)
timeFrame: 6 Months, 12 Months
measure: Right Ventricular Assist Device (RVAD) implantation or heart transplant
timeFrame: 12 Months
measure: Tricuspid valve surgery or percutaneous tricuspid intervention
timeFrame: 12 Months
measure: Heart Failure Events
timeFrame: 12 Months
Secondary outcomes:
measure: Secondary Safety Endpoint (measured at 1 year)
timeFrame: 12 Months
measure: All-Cause mortality
timeFrame: 3 Months, 6 Months, and 12 Months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ Score)
timeFrame: 3 Months, 6 Months, and 12 Months
measure: Right Ventricular Assist Device (RVAD) implantation or heart transplant
timeFrame: 3 Months, 6 Months, and 12 Months
measure: Six Minute Walking Test (6MWT)
timeFrame: 3 Months, 6 Months, and 12 Months
measure: Atrial Fibrillation
timeFrame: 3 Months, 6 Months, and 12 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: San Diego
country: United States
facility: Scripps Memorial Hospital La Jolla
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Evanston
country: United States
facility: Northshore Evanston Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Ascension Medical Group St. Vincent The Heart Center of Indiana
state: Indiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Irving
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Harrisburg
country: United States
facility: UPMC Pinnacle
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: University of Texas (Memorial Hermann)
state: Texas
city: Murray
country: United States
facility: Intermountain Heart Institute - Intermountain Medical Center
state: Utah
city: Multiple Locations
country: United States
facility: MedStar Washington Hospital Center
state: Washington
Study officials:
References:
citation: Amat-Santos IJ, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Blasco-Turrion S, Sanchez-Luna JP, Revilla-Orodoea A, Redondo A, Zamorano JL, Puri R, Iniguez-Romo A, San Roman A. Right heart remodelling after bicaval TricValve implantation in patients with severe tricuspid regurgitation. EuroIntervention. 2023 Aug 7;19(5):e450-e452. doi: 10.4244/EIJ-D-23-00077. No abstract available.
citation: Blasco-Turrion S, Briedis K, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Sanchez-Luna JP, Gonzalez-Gutierrez JC, Revilla-Orodoea A, Zamorano JL, Gomez-Salvador I, Puri R, San Roman JA, Amat-Santos IJ. Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes. JACC Cardiovasc Interv. 2024 Jan 8;17(1):60-72. doi: 10.1016/j.jcin.2023.10.043. Epub 2023 Dec 6.