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

NCT ID: NCT07140562

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this clinical trial is to evaluate the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation.

Conditions

Tricuspid Regurgitation Functional; Tricuspid Regurgitation (TR); Tricuspid Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tangent Tricuspid Annular Therapy System Treatment Group

Subjects will receive the experimental device according to the protocol. Primary safety and technical efficacy will be assessed, as well as secondary performance measures.

Group Type: EXPERIMENTAL

Tricuspid Annular Therapy System

Intervention Type: DEVICE

A transcatheter device designed for tricuspid valve repair.

Interventions

Tricuspid Annular Therapy System

A transcatheter device designed for tricuspid valve repair.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tangent Cardiovascular Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sanatorio Italiano

Asunción, , Paraguay

Site Status: RECRUITING

Countries

Paraguay

Facility Contacts

Dr. Adrian Ebner

Role: primary

adrian_ebner@yahoo.com

595-21-202-767

Other Identifiers

CD-001

Identifier Type: -

Identifier Source: org_study_id