Clinical trial Recruiting at 1 site Observational Ages 18 and up

Characterizing patients and outcomes in severe tricuspid regurgitation

Official title: ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation

Run by Medical University of Warsaw · NCT06838611 · Data updated 2026-11-12

This study looks at people with severe tricuspid regurgitation to see who can get a new heart valve treatment and how well it works for them.

More Heart Failure trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorMedical University of Warsaw
Academic / other
Locations1 site (Warsaw, Masovian Voivodeship)
StatusRecruiting
StartedNovember 14, 2023
Main results expectedNovember 14, 2027
Study endsJuly 1, 2028
Registry record updatedFebruary 20, 2025
Trial IDNCT06838611 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with severe tricuspid regurgitation who are being evaluated for transcatheter tricuspid valve intervention.

Probably not a fit

Patients with tricuspid regurgitation who are qualified for surgical treatment or have concomitant left heart valve disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize patients eligible for transcatheter tricuspid valve interventions (TTVI) by enrolling individuals referred to tertiary-care centers for severe tricuspid regurgitation. The study will describe patient profiles, identify common reasons for disqualification from TTVI, and evaluate both the immediate and long-term efficacy and safety of the intervention. Participants will undergo standard qualification procedures followed by clinical examinations, echocardiography, and laboratory tests to monitor outcomes.

Why it matters

Potential benefit: If successful, this study could improve the understanding of patient profiles and treatment outcomes for those with severe tricuspid regurgitation, potentially leading to better-targeted interventions.

How similar studies have gone: While this study focuses on a specific patient population and intervention, similar observational studies have shown promise in characterizing patient outcomes in valve disease interventions.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* tricuspid regurgitation
* qualification for transcatheter tricuspid valve intervention

Exclusion Criteria:

* tricuspid regurgitation qualified for surgical treatment
* concomitant left heart valve disease qualified for surgical treatment
* multivessel coronary artery disease qualified for coronary artery bypass grafting
* lack of patient's consent to enter the registry

Where it's running

  • First Department of Cardiology, Medical University of Warsaw
    Warsaw, Masovian Voivodeship, Poland
    Recruiting

Study contacts

  • Principal investigator: Adam Rdzanek, MD PhD — First Department of Cardiology, Medical University of Warsaw
  • Study coordinator: Adam Rdzanek, MD PhD
  • Email: adam.rdzanek@wum.edu.pl
  • Phone: 4822 599 19 51

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Registry for transcatheter repair of tricuspid regurgitation

    This study is collecting information on how well transcatheter repairs or replacements for the tricuspid valve work for people with tricuspid regurgitation to help improve treatment choices for them.

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    Recruiting Baker Heart and Diabetes Institute · Alice Springs, Northern Territory · NCT05558605

  • Follow-up of patients treated with TricValve® for heart valve issues

    This study follows patients who have had treatment for severe tricuspid regurgitation using the TricValve® system to see how well the valve is working over the next five years.

    Recruiting at 12 sites P+F Products + Features GmbH · Sankt Pölten, Lower Austria and 27 other locations · NCT05114850

  • Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

    Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.