Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement

Study acronym: GUIDE-TAVI
StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated September 19, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Secondary endpoints: details revised at 2 of 13 entriesv3
  3. Secondary endpoints revised (13)
    • Site details revised at 1 of 2 sites
    • Study title shortened, about 4 words
    v2
  4. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05788770
Lead Sponsor Romy Hegeman
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions
(from sponsor)		 Aortic Valve Stenosis
Related terms Aortic Valve Stenosis
Enrollment 454 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov