Actively Recruiting
Safety and Technical Feasibility Study of the Tangent Tricuspid Annular Therapy System for Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Led by Tangent Cardiovascular Inc. · Updated on 2025-08-24
25
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the safety and technical success of the Tangent Tricuspid Annular Therapy System in patients with severe, symptomatic functional tricuspid regurgitation. The study focuses on patients who have this condition despite optimal medical therapy and aims to assess device-related major adverse events and technical efficacy. Participants will receive the experimental Tangent device designed for transcatheter tricuspid valve repair. The study is single-arm and prospective, with safety and technical performance measured during and after the procedure, including hospital discharge assessments. Participants will undergo follow-up visits at 30 days, 90 days, 180 days, and 365 days post-procedure. During these visits, researchers will assess safety endpoints, technical success, functional class, quality of life, walking ability, and tricuspid regurgitation severity. The total participation may last up to one year after the procedure, with careful monitoring of outcomes and device performance.
CONDITIONS
Brief Title
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 90 years at the time of consent
- Symptomatic functional tricuspid regurgitation without co-existing degenerative disease despite optimal medical therapy for at least 30 days
- Severe, massive, or torrential functional tricuspid regurgitation confirmed by echocardiogram
- Adequate valve visualization by transesophageal echocardiogram for quantification and procedure guidance
- Suitable candidate for transcatheter tricuspid valve repair as determined by the local heart team
- Provided informed consent and agrees to attend all post-procedure follow-up visits
You will not qualify if you...
- Estimated life expectancy less than 12 months
- Systolic pulmonary artery pressure greater than 70 mmHg
- Acutely decompensated condition with low blood pressure or uncontrolled hypertension within 30 days of procedure
- Severe chronic obstructive pulmonary disease requiring home oxygen
- Severe right ventricular dysfunction seen on echocardiogram
- Severe valve stenosis or regurgitation of aortic, mitral, or pulmonic valves needing treatment
- Conditions interfering with the procedure such as prior tricuspid repair, abnormal valve anatomy, or device leads blocking placement
- Tricuspid valve stenosis with orifice area ≤1.0 cm2 or mean gradient ≥5 mmHg
- Intracardiac masses, thrombus, or infection in right heart chambers or superior vena cava
- Degenerative or rheumatic tricuspid valve disease
- Recent cardiovascular or carotid surgery within 30 days
- Recent implant or revision of rhythm management devices within 90 days
- Planned surgery within 30 days after procedure or cardiac surgery within 12 months
- Recent stroke or major cerebrovascular event within 90 days
- Untreated coronary artery disease needing revascularization or recent acute coronary syndrome
- Recent gastrointestinal bleeding or contraindication to anticoagulation
- Bleeding disorders or abnormal platelet counts
- Chronic anemia requiring transfusions with low hemoglobin
- Current or planned pregnancy within 12 months for women of childbearing potential
- Recent or active infection requiring antibiotics
- Prior tricuspid repair or replacement that interferes with device deployment
- Participation in other cardiac investigational studies
- Other medical, social, or psychological conditions limiting participation or follow-up
- Vulnerable patient status
- Left ventricular ejection fraction below 30%
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- Severe liver disease classified as Child-Pugh C cirrhosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (procedure day)
Participants receive the transcatheter device designed for tricuspid valve repair during a procedure.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and efficacy outcomes after the device placement.
Visits at 30, 90, 180, and 365 days post-procedure
Trial Site Locations
Total: 1 location
1
Sanatorio Italiano
Asunción, Paraguay
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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