TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.
NCT ID: NCT06458907
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
600 participants
INTERVENTIONAL
2024-12-31
2030-01-31
Brief Summary
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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.
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Detailed Description
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The TricValve System received Breakthrough Device Designation from the US FDA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TricValve® Device (Device) + Optimal medical therapy (OMT)
TricValve® Device (Device) + OMT
TricValve® Transcatheter Bicaval Valve System
TricValve® Device (Device) Group subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies.
Optimal medical therapy
Optimal medical therapy
Optimal medical therapy (OMT) Alone
OMT can prevent heart attacks and heart failure with medications like blood thinners, cholesterol drugs, and blood pressure meds.
Optimal medical therapy
Optimal medical therapy
TricValve Single Arm Registry
Patients who fulfil any of the screening criteria to participate in a parallel singe-arm registry.
TricValve® Transcatheter Bicaval Valve System
TricValve® Device (Device) Group subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies.
Optimal medical therapy
Optimal medical therapy
Interventions
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TricValve® Transcatheter Bicaval Valve System
TricValve® Device (Device) Group subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies.
Optimal medical therapy
Optimal medical therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Meditrial USA Inc.
INDUSTRY
P+F Products + Features USA Inc.
INDUSTRY
Responsible Party
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Locations
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St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Scripps Memorial Hospital La Jolla
San Diego, California, United States
Tampa General Hospital
Tampa, Florida, United States
Northshore Evanston Hospital
Evanston, Illinois, United States
Ascension Medical Group St. Vincent The Heart Center of Indiana
Indianapolis, Indiana, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
Irving, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Pinnacle
Harrisburg, Pennsylvania, United States
Houston Methodist
Houston, Texas, United States
University of Texas (Memorial Hermann)
Houston, Texas, United States
Intermountain Heart Institute - Intermountain Medical Center
Murray, Utah, United States
MedStar Washington Hospital Center
Multiple Locations, Washington, United States
Countries
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Central Contacts
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References
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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.
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.
Related Links
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Products \& Features, manufacturer of TricValve® Transcatheter Bicaval Valve System
Meditrial Clinical Research Organization
Other Identifiers
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CTP-TRIC-005-II
Identifier Type: -
Identifier Source: org_study_id
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