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 Type
OBSERVATIONAL
Enrollment
500
Herz- und Diabeteszentrum
Bad Oeynhausen, North Rhine-Westphalia, Germany
RECRUITINGMortality
Detection of mortality after transcatheter tricuspid intervention
Time frame: 1 year
Residual Tricuspid Regurgitation
Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention
Time frame: At discharge, 30 days and 1 year
rehospitalization rate
Detection of rehospitalization rate after transcatheter tricuspid intervention
Time frame: 1 year
reintervention rate
Detection of reintervention rate on the tricuspid valve after transcatheter tricuspid intervention
Time frame: 1 year
NYHA Class
Changes on New York Heart Association functional class after transceather tricuspid valve intervention
Time frame: 30 days and 1 year
Intraprocedural success
All of the following must be present: 1. Absence of intraprocedural mortality or stroke; and 2. Successful access, delivery, and retrieval of the device delivery system; and 3. Successful deployment and correct positioning of the intended device(s) without requiring implantation of unplanned additional devices; and 4. 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 5. Absence of device-related obstruction of forward flow 6. Absence of device-related pulmonary embolism 7. Freedom from emergency surgery or reintervention during the first 24 h related to the device or access procedure
Time frame: 30 days
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