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

NCT07140562 | Recruiting

• 1 other identifier: CD-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint: Proportion of Patients Free From Device or Procedure-Related Major Adverse Events (MAEs) Through 30-Days Post-Procedure

  Freedom from device or procedure-related major adverse events (MAEs) through 30 days post-procedure, including: * Cardiovascular mortality * Stroke * Myocardial infarction * Major cardiac structural complications * Device-related pulmonary embolism (PE) * Severe bleeding defined by MVARC * Unplanned tricuspid valve re-intervention (percutaneous or surgical)

  30 days post-procedure

• Primary Technical and Efficacy Endpoint - Measure 1: Technical Success at Completion of the Procedure

  Technical success upon completion of the procedure in the catheterization lab or operating room, defined as: 1. Successful delivery and removal of the Delivery System; 2. Device implanted in the patient as intended.

  At completion of the index procedure

• Primary Technical and Efficacy Endpoint - Measure 2: Procedural Technical Success and TR ≤Moderate at Hospital Discharge

  Procedural success at discharge, defined as: 1. Achieved technical success; 2. TR classification of moderate or less

  At hospital discharge following the index procedure

Secondary Outcomes (4)

• Secondary Endpoint - NYHA Functional Class at 30, 90, 180, and 365-Days Post-Procedure

  30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)

• Secondary Endpoint - KCCQ at 30, 90, 180, and 365-Days Post-Procedure

  30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)

• Secondary Endpoint - 6MWT at 30, 90, 180, and 365-Days Post-Procedure

  30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)

• Secondary Endpoint - Tricuspid Regurgitation at 30, 90, 180, and 365-Days Post-Procedure

  30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)

Study Arms (1)

Tangent Tricuspid Annular Therapy System Treatment Group

EXPERIMENTAL

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

Device: Tricuspid Annular Therapy System

Interventions

Tricuspid Annular Therapy System DEVICE

A transcatheter device designed for tricuspid valve repair.

Tangent Tricuspid Annular Therapy System Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old at the time of consent
• 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
• Severe, massive or torrential functional tricuspid regurgitation, as determined by qualifying transesophageal echocardiogram (TEE) and/or transthoracic echocardiogram (TTE) using the 5-grade classification
• TEE imaging confirms adequate visualization of valve for TR quantification and procedural guidance
• The Local Heart Team determines the candidate is suitable for transcatheter tricuspid valve repair
• Subject or legally authorized representative has provided informed consent and agrees to return for all required post-procedure follow-up visits

You may not qualify if:

• Estimated life expectancy of less than 12 months
• Systolic pulmonary artery pressure (sPAP) \>70 mmHg as assessed by TTE or right heart catheterization
• 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
• Severe COPD dependent on home oxygen or chronic home oxygen use
• Echocardiographic evidence of severe right ventricular dysfunction
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment (prior transcatheter or surgical treatment allowable)
• 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)
• Tricuspid valve stenosis defined as a tricuspid valve orifice of ≤1.0 cm2 and/or mean gradient of ≥5 mmHg
• New or untreated right heart chamber and/or superior vena cava intracardiac mass, thrombus, or vegetation
• Degenerative tricuspid or rheumatic tricuspid valve disease
• Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the study procedure
• Implant or revision of any rhythm management device (CRT or CRT-D, ICD, or leadless pacemaker) within 90 days prior to the study procedure
• 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
• Stroke or other major cerebrovascular event within 90 days prior to the study procedure
• Untreated clinically significant coronary artery disease requiring revascularization, recent (within 30 days of the study procedure) acute coronary syndrome or myocardial infarction

Sponsors & Collaborators

• Tangent Cardiovascular Inc.: lead

Study Sites (1)

Sanatorio Italiano

Asunción, Paraguay

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 24, 2025
• Study Start: July 15, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

PA (1)