An interventional study of Tricuspid Annular Therapy System in Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR) and Tricuspid Regurgitation, sponsored by Tangent Cardiovascular Inc.. Recruiting at 1 site in Paraguay. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Tangent Cardiovascular Inc. · Not applicable, Interventional, and Treatment
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.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 128 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →This is the only study on the registry with Tangent Cardiovascular Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive the experimental device according to the protocol. Primary safety and technical efficacy will be assessed, as well as secondary performance measures.
Device: Tricuspid Annular Therapy System
A transcatheter device designed for tricuspid valve repair.
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)
Time frame: 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: 1. Successful delivery and removal of the Delivery System; 2. Device implanted in the patient as intended.
Time frame: 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: 1. Achieved technical success; 2. TR classification of moderate or less
Time frame: At hospital discharge following the index procedure
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: a) New York Heart Association (NYHA) functional class
Time frame: 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: b) KCCQ
Time frame: 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: c) 6-minute walk test
Time frame: 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: d) Tricuspid regurgitation
Time frame: 30 days (±7 days); 90 days (±30 days); 180 days (±30 days); 365 days (±60 days)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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