CT Prediction for Transcatheter Tricuspid Interventions

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeart and Diabetes Center North-Rhine Westfalia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

none

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Mortality

Detection of mortality after transcatheter tricuspid intervention

Time frame
1 year

Secondary outcomes

1

Residual Tricuspid Regurgitation

Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention

Time frame
At discharge, 30 days and 1 year
2

rehospitalization rate

Detection of rehospitalization rate after transcatheter tricuspid intervention

Time frame
1 year
3

reintervention rate

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

Time frame
1 year
4

NYHA Class

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

Time frame
30 days and 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart and Diabetes Center North-Rhine Westfalia

Lead sponsor

Ludwig-Maximilians - University of Munich

Collaborator

University Hospital Schleswig-Holstein

Collaborator

University of Cologne

Collaborator

Heart Center Leipzig - University Hospital

Collaborator

Charite University, Berlin, Germany

Collaborator

University of Bern

Collaborator

University Medical Center Mainz

Collaborator