Actively Recruiting
Safety and Feasibility Study: 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
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 90 years at the time of consent
- Symptomatic functional tricuspid regurgitation despite optimal medical therapy for at least 30 days
- Severe, massive, or torrential functional tricuspid regurgitation confirmed by qualifying echocardiogram
- Adequate valve visualization on transesophageal echocardiogram for valve assessment and procedure guidance
- Determined suitable for transcatheter tricuspid valve repair by the local heart team
- Provided informed consent and agrees to attend all follow-up visits
You will not qualify if you...
- Life expectancy less than 12 months
- Systolic pulmonary artery pressure over 70 mmHg
- Acutely decompensated heart condition within 30 days before the procedure
- Severe chronic obstructive pulmonary disease requiring home oxygen
- Severe right ventricular dysfunction seen on echocardiogram
- Severe aortic, mitral, or pulmonic valve disease requiring treatment
- Conditions interfering with the procedure, such as prior tricuspid valve repair or certain heart device leads
- Tricuspid valve stenosis with valve orifice ≤1.0 cm2 or mean gradient ≥5 mmHg
- Presence of untreated right heart or superior vena cava masses or infections
- Degenerative or rheumatic tricuspid valve disease
- Cardiovascular interventions or surgeries within 30 days before the procedure
- Rhythm device implant or revision within 90 days before the procedure
- Planned surgeries or interventions within 30 days after or cardiac surgery within 12 months after the procedure
- Stroke or major cerebrovascular event within 90 days before the procedure
- Untreated significant coronary artery disease or recent acute coronary syndrome
- Active or recent gastrointestinal bleeding or contraindication to oral anticoagulation
- Blood disorders affecting platelets or anemia requiring transfusion
- Current or planned pregnancy within 12 months for women of childbearing potential
- Active or recent endocarditis or systemic infection requiring antibiotics
- Prior tricuspid valve repair or replacement interfering with device placement
- Participation in another cardiac investigational device or drug study
- Other medical, social, or psychological conditions limiting participation or follow-up
- Vulnerable patient status
- Left ventricular ejection fraction less than 30%
- Deep vein thrombosis or pulmonary embolism within 6 months
- Child-Pugh C cirrhosis
AI-Screening
AI-Powered Screening
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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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