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 volunteersQualifiers
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
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Mortality
Detection of mortality after transcatheter tricuspid intervention
Secondary outcomes
Residual Tricuspid Regurgitation
Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention
rehospitalization rate
Detection of rehospitalization rate after transcatheter tricuspid intervention
reintervention rate
Detection of reintervention rate on the tricuspid valve after transcatheter tricuspid intervention
NYHA Class
Changes on New York Heart Association functional class after transceather tricuspid valve intervention
Sponsors and contacts
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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