Actively Recruiting
Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
Led by Romy Hegeman · Updated on 2024-09-19
454
Participants Needed
2
Research Sites
142 weeks
Total Duration
On this page
Sponsors
R
Romy Hegeman
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders. The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.
CONDITIONS
Official Title
Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary symptomatic severe aortic valve stenosis
- Accepted for TAVR via transfemoral, transsubclavian, or transapical access
- Plan to implant one of the following valves: CoreValve Evolut R, Evolut PRO, Evolut PRO+, ACURATE neo, or ACURATE neo 2
- Provided informed consent
You will not qualify if you...
- Previous surgical aortic valve replacement
- Permanent pacemaker at the start of the study
- Emergency procedure
- Poor CT image quality preventing computer simulation
- Declined informed consent or refused participation
- Unable to understand the informed consent or study details
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Vienna General Hospital
Vienna, Austria
Actively Recruiting
2
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Actively Recruiting
Research Team
R
Romy Hegeman, MD
CONTACT
D
Dirk-Jan van Ginkel, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here