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NCT Number: NCT06951126

CT Prediction for Transcatheter Tricuspid Interventions

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location status: Recruiting

Location contact

Johannes Kirchner, Dr. med.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 1 year

    Detection of mortality after transcatheter tricuspid intervention

Secondary outcomes

  1. Residual Tricuspid Regurgitation

    Time frame: At discharge, 30 days and 1 year

    Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention

  2. rehospitalization rate

    Time frame: 1 year

    Detection of rehospitalization rate after transcatheter tricuspid intervention

  3. reintervention rate

    Time frame: 1 year

    Detection of reintervention rate on the tricuspid valve after transcatheter tricuspid intervention

  4. NYHA Class

    Time frame: 30 days and 1 year

    Changes on New York Heart Association functional class after transceather tricuspid valve intervention

  5. Intraprocedural success

    Time frame: 30 days

    All of the following must be present:

    • Absence of intraprocedural mortality or stroke; and
    • Successful access, delivery, and retrieval of the device delivery system; and
    • Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and
    • Adequate performance of the transcatheter device. Performance of devices whose purpose is a reduction in TR, should include the absence of tricuspid stenosis, reduction of total tricuspid regurgitation to optimal
    • Absence of device-related obstruction of forward flow
    • Absence of device-related pulmonary embolism
    • Freedom from emergency surgery or reintervention during the first 24 h related to the device or access procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Johannes Kirchner, Dr. med.

CONTACT

[email protected]

0405731971258

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Collaborators

  • Charite University, Berlin, Germany
  • Heart Center Leipzig - University Hospital
  • Ludwig-Maximilians - University of Munich
  • University Hospital Schleswig-Holstein
  • University Medical Center Mainz
  • University of Bern
  • University of Cologne

Registry information

Acronym: CESAR-TR

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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