CT Prediction for Transcatheter Tricuspid Interventions (CESAR-TR)

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.

Study Overview

• Status: Recruiting
• Conditions: Computed Tomography; Tricuspid Regurgitation

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Johannes Kirchner, Dr. med.; Phone Number: 0405731971258; Email: jkirchner@hdz-nrw.de

Study Locations

• Germany
  • NRW
    • Bad Oeynhausen, NRW, Germany, 32545
      • Recruiting
      • Herz- und Diabeteszentrum
      • Contact: Johannes Kirchner, Dr. med.; Email: jkirchner@hdz-nrw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study includes patients with >moderate tricuspid regurgitation who underwent cardiac computed tomography and transcatheter tricupid valve intervention.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Detection of mortality after transcatheter tricuspid intervention	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Tricuspid Regurgitation	Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention	At discharge, 30 days and 1 year
rehospitalization rate	Detection of rehospitalization rate after transcatheter tricuspid intervention	1 year
reintervention rate	Detection of reintervention rate on the tricuspid valve after transcatheter tricuspid intervention	1 year
NYHA Class	Changes on New York Heart Association functional class after transceather tricuspid valve intervention	30 days and 1 year
Intraprocedural success	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	30 days

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Collaborators: Charite University, Berlin, Germany; University of Cologne; Ludwig-Maximilians - University of Munich; University of Bern; University Hospital Schleswig-Holstein; Heart Center Leipzig - University Hospital; University Medical Center Mainz

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2030

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: MSCT; TR; Tricuspid regurgitation; transcatheter tricuspid valve intervention; TTVI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: HDZ-KA CESAR-TR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No