Actively Recruiting
ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
Led by Medical University of Warsaw · Updated on 2025-02-20
300
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
Sponsors
M
Medical University of Warsaw
Lead Sponsor
P
Poznan University of Medical Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand patients with severe tricuspid regurgitation who are considered for transcatheter tricuspid valve interventions (TTVI). It seeks to describe patient profiles, reasons for disqualification from TTVI, and to evaluate both the immediate and long-term effectiveness and safety of these procedures. The study is observational and enrolls patients referred to specialized centers for evaluation and potential treatment of tricuspid valve disease. Participants may be qualified or disqualified for various interventions based on detailed heart imaging and clinical assessments. Those qualified might receive transcatheter tricuspid valve edge-to-edge repair (T-TEER) or other procedures like mitral valve repair, aortic valve implantation, or device implantations. Patients disqualified from TTVI receive medical therapy and follow-up. The enrollment lasts 36 months with each patient followed for 12 months or longer, including multiple clinical and imaging assessments at defined intervals. During the study, participants undergo clinical exams, echocardiography, laboratory tests, and assessments of heart function and aerobic capacity. Data on symptoms, heart failure status, and treatment outcomes are collected regularly, both in clinics and remotely if needed. The main outcomes include mortality and heart failure hospitalizations over 24 months, with additional measures of valve function, aerobic capacity, and quality of life. The study follows strict ethical guidelines and informed consent is obtained from all patients.
CONDITIONS
Brief Title
ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with tricuspid regurgitation
- Qualified for transcatheter tricuspid valve intervention
- Age 18 years or older
- Able and willing to provide informed consent
You will not qualify if you...
- Qualified for surgical treatment of tricuspid regurgitation
- Qualified for surgical treatment of concomitant left heart valve disease
- Qualified for coronary artery bypass grafting due to multivessel coronary artery disease
- Lack of patient's consent to enter the registry
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during index hospitalization with clinical assessment and informed consent
Duration - Within index hospitalization
Participants undergo clinical assessments, transthoracic echocardiography (TTE), and other imaging to confirm severity of tricuspid regurgitation and to evaluate anatomy for possible interventions.
1 visit (in-person) during index hospitalization
Duration - Up to index hospitalization and immediate post-procedure period
Participants either receive transcatheter edge-to-edge repair (T-TEER) or medical therapy depending on qualification. Those undergoing other non-tricuspid interventions will be reassessed before final treatment decision.
1 procedure visit (in-person) plus hospitalization period up to 7 days post-procedure
Duration - 12 months or longer
Participants are followed up with clinical, laboratory, and echocardiographic assessments to monitor treatment outcomes and heart failure status.
Outpatient visits at 1, 3, 6, and 12 months after treatment or medical therapy initiation, then annually
Trial Site Locations
Total: 1 location
1
First Department of Cardiology, Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 02-091
Actively Recruiting
Research Team
A
Adam Rdzanek, MD PhD
M
Mariusz Tomaniak, MD PhD Assoc. Prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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