Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation

Launched by TANGENT CARDIOVASCULAR INC. · Aug 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new, less invasive treatment for people with severe tricuspid regurgitation, a condition where one of the heart’s valves doesn’t close properly, causing blood to flow backward. The treatment uses a device called the Tangent Tricuspid Annular Therapy System to repair the valve through a small tube inserted into the body, instead of open-heart surgery. The main goal is to see if this procedure is safe and technically successful in helping patients who have symptoms despite taking the best available medicines.

People who may be eligible are adults aged 18 to 90 who have severe symptoms caused by this valve problem, confirmed by heart imaging tests. They must have already tried the usual medical treatments for at least a month without enough improvement. Before joining, doctors will check if the valve can be properly seen and treated with the device. If accepted, participants will undergo the procedure and then have follow-up visits to monitor their progress. Some health conditions, like very advanced heart or lung disease, recent heart attacks, or certain infections, could make someone ineligible. This study is currently recruiting patients, and if you or a loved one fits these criteria, talking to your heart doctor about this option might be worthwhile.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18-90 years old at the time of consent
• • 2. Symptomatic functional tricuspid regurgitation (without co-existing degenerative disease) despite being adequately treated with optimal medical therapy by the Local Heart Team for at least 30 days prior to the study consent
• • 3. Severe, massive or torrential functional tricuspid regurgitation, as determined by qualifying transesophageal echocardiogram (TEE) and/or transthoracic echocardiogram (TTE) using the 5-grade classification
• • 4. TEE imaging confirms adequate visualization of valve for TR quantification and procedural guidance
• • 5. The Local Heart Team determines the candidate is suitable for transcatheter tricuspid valve repair
• • 6. Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits
• Exclusion Criteria:
• • 1. Estimated life expectancy of less than 12 months
• • 2. Systolic pulmonary artery pressure (sPAP) \>70 mmHg as assessed by TTE or right heart catheterization
• • 3. Acutely decompensated, defined as hypotension with SBP \<90 mmHg, use of hemodynamic support devices or inotropes or uncontrolled arterial hypertension with SBP \>180 mmHg within 30 days of the study procedure
• • 4. Severe COPD dependent on home oxygen or chronic home oxygen use
• • 5. Echocardiographic evidence of severe right ventricular dysfunction
• • 6. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment (prior transcatheter or surgical treatment allowable)
• • 7. Any condition that would interfere with the procedure, such as prior tricuspid valve repair, tricuspid valve leaflet anatomy which may preclude device implantation, pacemaker or Implantable Cardioverter Defibrillator (ICD) leads that would prevent appropriate placement or visualization of implant, Ebstein Anomaly (normal annulus position, but valve leaflets attached to walls and septum of the right ventricle)
• • 8. Tricuspid valve stenosis defined as a tricuspid valve orifice of ≤1.0 cm2 and/or mean gradient of ≥5 mmHg
• • 9. New or untreated right heart chamber and/or superior vena cava intracardiac mass, thrombus, or vegetation
• • 10. Degenerative tricuspid or rheumatic tricuspid valve disease
• • 11. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the study procedure
• • 12. Implant or revision of any rhythm management device (CRT or CRT-D, ICD, or leadless pacemaker) within 90 days prior to the study procedure
• • 13. Known need for emergent, urgent, or planned surgery or intervention within 30 days following the study procedure, or planned or scheduled cardiac surgery within 12 months following the study procedure
• • 14. Stroke or other major cerebrovascular event within 90 days prior to the study procedure
• • 15. Untreated clinically significant coronary artery disease requiring revascularization, recent (within 30 days of the study procedure) acute coronary syndrome or myocardial infarction
• • 16. Active or recent GI bleed within 30 days prior to the study procedure, or patients contraindicated for oral anticoagulation therapy
• • 17. Bleeding disorders including thrombocytopenia (platelet count \<70,000 mm3) or thrombocytosis (platelet count \>700,000 mm3)
• • 18. Transfusion-dependent chronic anemia with Hb \<9/dL
• • 19. Current or planned pregnancy within 12 months of the study procedure for women of childbearing potential
• • 20. Active or recent endocarditis within 90 days of the study procedure, or sepsis/other systemic infection requiring oral or intravenous antibiotics within 30 days of the study procedure
• • 21. Prior tricuspid repair or tricuspid replacement or prosthetic implant that would interfere with successful deployment or functioning of the Tangent Implant
• • 22. Participation in another pre-market investigational device study or investigational drug study (for a cardiac-related drug)
• • 23. Presence of other anatomic or co-morbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's availability to participate in the clinical investigation or to comply with follow-up requirements
• • 24. Any patient considered to be vulnerable
• • 25. Left ventricular ejection fraction (LVEF) \<30%
• • 26. Deep vein thrombosis or pulmonary embolism within 6 months of the study procedure
• • 27. Child-Pugh C cirrhosis