Health Trials

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

ConditionsTricuspid Regurgitation FunctionalTricuspid Regurgitation (TR)Tricuspid Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorTangent Cardiovascular Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-90 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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Tricuspid Annular Therapy System

    Device

    A transcatheter device designed for tricuspid valve repair.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Tangent Tricuspid Annular Therapy System Treatment GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
30 days post-procedure
2

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.

Time frame
At completion of the index procedure
3

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

Time frame
At hospital discharge following the index procedure

Secondary outcomes

1

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

Change from baseline at 30-, 90-, 180-, and 365-days post-procedure in the following: a) New York Heart Association (NYHA) functional class

Time frame
30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
2

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

Change from baseline at 30-, 90-, 180-, and 365-days post-procedure in the following: b) KCCQ

Time frame
30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
3

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

Change from baseline at 30-, 90-, 180-, and 365-days post-procedure in the following: c) 6-minute walk test

Time frame
30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
4

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

Change from baseline at 30-, 90-, 180-, and 365-days post-procedure in the following: d) Tricuspid regurgitation

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tangent Cardiovascular Inc.

Lead sponsor

Source ClinicalTrials.gov
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