Tricuspid Regurgitation FunctionalNCT07140562
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
A study testing Tricuspid Annular Therapy System in people with Tricuspid Regurgitation Functional and Tricuspid Regurgitation (TR), run by Tangent Cardiovascular Inc. at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR), Tricuspid Regurgitation
- What is being tested?
- Tricuspid Annular Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteParaguay
- Study dates
- 15 Jul 2025to Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- 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)
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- 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
- New or untreated right heart chamber and/or superior vena cava intracardiac mass, thrombus, or vegetation
- Degenerative tricuspid or rheumatic tricuspid valve disease
- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days of the study procedure
- Implant or revision of any rhythm management device (CRT or CRT-D, ICD, or leadless pacemaker) within 90 days prior to the study procedure
- Known need for emergent, urgent, or planned surgery or intervention within 30 days following the study procedure, or planned or scheduled cardiac surgery within 12 months following the study procedure
- Stroke or other major cerebrovascular event within 90 days prior to the study procedure
- Untreated clinically significant coronary artery disease requiring revascularization, recent (within 30 days of the study procedure) acute coronary syndrome or myocardial infarction
- Active or recent GI bleed within 30 days prior to the study procedure, or patients contraindicated for oral anticoagulation therapy
- Bleeding disorders including thrombocytopenia (platelet count <70,000 mm3) or thrombocytosis (platelet count >700,000 mm3)
- Transfusion-dependent chronic anemia with Hb <9/dL
- Current or planned pregnancy within 12 months of the study procedure for women of childbearing potential
- Active or recent endocarditis within 90 days of the study procedure, or sepsis/other systemic infection requiring oral or intravenous antibiotics within 30 days of the study procedure
- Prior tricuspid repair or tricuspid replacement or prosthetic implant that would interfere with successful deployment or functioning of the Tangent Implant
- Participation in another pre-market investigational device study or investigational drug study (for a cardiac-related drug)
- Presence of other anatomic or co-morbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's availability to participate in the clinical investigation or to comply with follow-up requirements
- Any patient considered to be vulnerable
- Left ventricular ejection fraction (LVEF) <30%
- Deep vein thrombosis or pulmonary embolism within 6 months of the study procedure
- Child-Pugh C cirrhosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paraguay1 site, 1 recruiting
- Recruiting
Sanatorio Italiano
Asunción
Dr. Adrian Ebner, 595-21-202-767, adrian_ebner@yahoo.com
About this study
Official title: Prospective, Multi-Center, Single-Arm Study: Safety and Technical Feasibility of the Tangent Tricuspid Annular Therapy System for Transcatheter Valve Repair in Patients With Severe, Symptomatic Functional Tricuspid Regurgitation
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.
- Being tested
- Tricuspid Annular Therapy System
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid Annular Therapy SystemDevice
A transcatheter device designed for tricuspid valve repair.
| Study group | Role | What they receive |
|---|---|---|
| Tangent Tricuspid Annular Therapy System Treatment Group | Experimental | Subjects will receive the experimental device according to the protocol. Primary safety and technical efficacy will be assessed, as well as secondary performance measures. Receives: Device: Tricuspid Annular Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days post-procedure
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:
- Successful delivery and removal of the Delivery System;
- Device implanted in the patient as intended.
Measured: At completion of the index procedure
Primary Technical and Efficacy Endpoint - Measure 2: Procedural Technical Success and TR ≤Moderate at Hospital Discharge
Procedural success at discharge, defined as:
- Achieved technical success;
- TR classification of moderate or less
Measured: At hospital discharge following the index procedure
Secondary outcomes (4)
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:
- New York Heart Association (NYHA) functional class
Measured: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
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:
- KCCQ
Measured: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
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:
- 6-minute walk test
Measured: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
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:
- Tricuspid regurgitation
Measured: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start15 Jul 2025
- Primary completionAug 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tangent Cardiovascular Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140562
- Sponsor's protocol ID
- CD-001
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No