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Clinical Trials/NCT06951126
NCT06951126RecruitingNot Applicable

CT Prediction for Transcatheter Tricuspid Interventions

Heart and Diabetes Center North-Rhine Westfalia1 site in 1 country500 target enrollmentStarted: July 19, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
500
Locations
1
Primary Endpoint
Mortality

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Outcomes

Primary Outcomes

Mortality

Time Frame: 1 year

Detection of mortality after transcatheter tricuspid intervention

Secondary Outcomes

  • Residual Tricuspid Regurgitation(At discharge, 30 days and 1 year)
  • rehospitalization rate(1 year)
  • reintervention rate(1 year)
  • NYHA Class(30 days and 1 year)
  • Intraprocedural success(30 days)

Investigators

Sponsor
Heart and Diabetes Center North-Rhine Westfalia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Johannes Kirchner

Dr. med.

Heart and Diabetes Center North-Rhine Westfalia

Study Sites (1)

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