Actively Recruiting
CT Prediction for Transcatheter Tricuspid Interventions
Led by Heart and Diabetes Center North-Rhine Westfalia · Updated on 2025-04-30
500
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
H
Heart and Diabetes Center North-Rhine Westfalia
Lead Sponsor
L
Ludwig-Maximilians - University of Munich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how to better predict the success of transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). Severe TR often leads to poor outcomes, and traditional treatments like medication become less effective in advanced stages, while surgery carries high risks. This observational study focuses on using artificial intelligence (AI) to analyze pre-interventional computed tomography (CT) scans to improve patient selection and treatment planning. The study uses AI-powered software to automatically measure heart structures from CT imaging, enabling detailed three-dimensional analysis of the right heart anatomy. This approach aims to identify which patients might benefit most from different catheter-based treatment options, such as annuloplasty, leaflet-based repair, or valve replacement. The research is conducted through a multi-center collaboration analyzing outcomes after TTVI procedures. Participants will have undergone full-cycle cardiac CT scans and received TTVI. Researchers will monitor outcomes including mortality at one year, residual tricuspid regurgitation at discharge and follow-ups, rehospitalization, reintervention rates, symptom improvement measured by NYHA class, and intraprocedural success. The study spans assessments at discharge, 30 days, and one year, aiming to refine treatment strategies and improve quality of life in severe TR patients.
CONDITIONS
Brief Title
CT Prediction for Transcatheter Tricuspid Interventions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient underwent full cycle cardiac computed tomography for analysis of valvular heart disease
- A transcatheter tricuspid valve intervention is performed
- The patient is 18 years or older
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo a full cycle cardiac computed tomography to analyze valvular heart disease prior to intervention.
1 visit (in-person)
Duration - Until discharge
Participants undergo transcatheter tricuspid valve intervention and receive immediate post-operative care.
1 procedure visit and hospital stay
Duration - 1 year
Participants are monitored for residual tricuspid regurgitation, rehospitalization, reintervention, and functional status.
Visits at discharge, 30 days, and 1 year
Trial Site Locations
Total: 1 location
1
Herz- und Diabeteszentrum
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Actively Recruiting
Research Team
J
Johannes Kirchner, Dr. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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