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CT Prediction for Transcatheter Tricuspid Interventions (CESAR-TR)

H

Heart and Diabetes Center North-Rhine Westfalia

Status

Enrolling

Conditions

Computed Tomography
Tricuspid Regurgitation

Study type

Observational

Funder types

Other

Identifiers

NCT06951126
HDZ-KA CESAR-TR

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • none

Trial contacts and locations

1

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Central trial contact

Johannes Kirchner, Dr. med.

Data sourced from clinicaltrials.gov

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