Characterizing patients and outcomes in severe tricuspid regurgitation
ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT06838611 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with severe tricuspid regurgitation who are being evaluated for transcatheter tricuspid valve intervention.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Warsaw, Masovian Voivodeship
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.