Actively Recruiting

Age: 18Years +
All Genders
ID06951126

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Surgery and Immediate Post-operative Care

Duration - Until discharge

Participants undergo transcatheter tricuspid valve intervention and receive immediate post-operative care.

1 procedure visit and hospital stay

Post-operative Follow-up

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

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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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