Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricusp… (NCT07140562) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Paraguay25 participantsStarted 2025-07-15
Plain-language 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.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Primary Safety Endpoint: Proportion of Patients Free From Device or Procedure-Related Major Adverse Events (MAEs) Through 30-Days Post-Procedure
Timeframe: 30 days post-procedure
2
Primary Technical and Efficacy Endpoint - Measure 1: Technical Success at Completion of the Procedure
Timeframe: At completion of the index procedure
3
Primary Technical and Efficacy Endpoint - Measure 2: Procedural Technical Success and TR ≤Moderate at Hospital Discharge
Timeframe: At hospital discharge following the index procedure
. 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