Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional 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
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
Treatments tested in this trial
- Tricuspid Annular Therapy System
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov