Herz- und Diabeteszentrum
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Location status: Recruiting
NCT Number: NCT06951126
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Detection of mortality after transcatheter tricuspid intervention
Time frame: At discharge, 30 days and 1 year
Grade of residual tricuspid regurgitation after transcatheter tricuspid valve intervention
Time frame: 1 year
Detection of rehospitalization rate after transcatheter tricuspid intervention
Time frame: 1 year
Detection of reintervention rate on the tricuspid valve after transcatheter tricuspid intervention
Time frame: 30 days and 1 year
Changes on New York Heart Association functional class after transceather tricuspid valve intervention
Time frame: 30 days
All of the following must be present:
Contact information is provided by the study sponsor or research team.
Heart and Diabetes Center North-Rhine Westfalia
Other
Acronym: CESAR-TR
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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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