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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Status | Recruiting |
| Started | November 14, 2023 |
| Main results expected | November 14, 2027 |
| Study ends | July 1, 2028 |
| Registry record updated | February 20, 2025 |
| Trial ID | NCT06838611 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
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.