MedTrace Logo

CT Prediction for Transcatheter Tricuspid Interventions

NCT06951126 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-04-30

No results posted yet for this study

Summary

The aim of this study is to enhance the predictability of therapeutic success in transcatheter tricuspid valve intervention (TTVI) for patients with severe tricuspid regurgitation (TR). This will be achieved through automated analyses of pre-interventional computed tomography (CT) scans.

Severe tricuspid regurgitation is associated with poor patient outcomes. In advanced stages, pharmacological therapy becomes ineffective, and surgical intervention carries a high mortality risk. Given this clinical challenge, catheter-based treatment of the tricuspid valve has become a focal point of research.

One well-established treatment strategy is percutaneous tricuspid valve intervention, which aims to reduce regurgitation either through annuloplasty, leaflet-based edge-to-edge repair or valve replacement. This approach has been shown to significantly decrease the severity of regurgitation, leading to a dramatic reduction in symptom burden and a marked improvement in quality of life.

However, predicting which patients will benefit most from TTVI and determining the optimal technique for each individual remain largely unresolved challenges.

Artificial intelligence (AI)-powered software, such as heart.ai by LARALAB (Munich), enables automated measurement of anatomical structures captured via CT imaging. This technology already allows for rapid and precise assessment of cardiac chambers and the tricuspid annulus throughout the entire cardiac cycle, facilitating a comprehensive three-dimensional evaluation of right heart anatomy.

To refine patient selection and optimize procedural strategies for TR treatment, the researcher work a multi-center collaboration to analyze treatment outcomes and patient response to specific therapeutic approaches.

Conditions

  • Tricuspid Regurgitation
  • Computed Tomography

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    collaborator OTHER

  • University of Cologne

    collaborator OTHER

  • Heart Center Leipzig - University Hospital

    collaborator OTHER

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University of Bern

    collaborator OTHER

  • University Medical Center Mainz

    collaborator OTHER

  • Heart and Diabetes Center North-Rhine Westfalia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-19
Primary Completion
2026-06-01
Completion
2030-06-01

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06951126 on ClinicalTrials.gov