Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Primary symptomatic severe aortic valve stenosis

• Accepted for TAVR, either by transfemoral, transsubclavian or transapical access

• Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo 2™ (Boston Scientific, Marlborough, MA, USA)

• Informed consent

Locations
Other Locations
Austria
Vienna General Hospital
RECRUITING
Vienna
Netherlands
St. Antonius Hospital
RECRUITING
Nieuwegein
Contact Information
Primary
Romy Hegeman, MD
r.hegeman@antoniusziekenhuis.nl
+31 (0)6 41 71 16 79
Backup
Dirk-Jan van Ginkel, MD
d.van.ginkel@antoniusziekenhuis.nl
+31 (0) 88 320 66 48
Time Frame
Start Date: 2022-04-06
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 454
Treatments
Experimental: FEops HEARTGuide
Device selection using FEops HEARTGuide: 3D anatomical analysis and simulation of transcatheter aortic valve prosthesis prior to procedure based on computed tomography.
No_intervention: Standard transcatheter aortic valve implantation (no FEops HEARTGuide)
Control: standard of care, CT based device selection.
Sponsors
Leads: Romy Hegeman
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov