TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation.

Launched by P+F PRODUCTS + FEATURES USA INC. · Jun 12, 2024

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ClinConnect Summary

The TRICAV-II Pivotal trial is studying a new device called the TricValve Transcatheter Bicaval Valve System, which is designed to help patients with a severe heart condition known as tricuspid regurgitation. This condition happens when the tricuspid valve in the heart doesn’t close properly, causing blood to flow backward. The TricValve System consists of two specially designed valves that can be placed in the veins leading to the heart without needing to disturb the existing tricuspid valve. This procedure is done through a small cut in the leg and is intended for patients who have severe symptoms of heart failure.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of severe tricuspid regurgitation, along with certain heart failure symptoms. They should also have been on stable heart treatment for the last month. However, there are specific conditions that would make someone ineligible, such as recent heart attacks or major surgeries. If someone joins the trial, they can expect to receive close monitoring and care during and after the procedure. This trial aims to provide a new treatment option for those struggling with this serious condition, potentially improving their quality of life.

Gender

ALL

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.