Status:
UNKNOWN
Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Feops
Conditions:
Aortic Valve Stenosis
Bicuspid Cardiac Valve
Eligibility:
All Genders
18+ years
Brief Summary
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (...
Detailed Description
Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat patients with severe aortic stenosis. However, by extending the indication for TAVI, simulation may become increa...
Eligibility Criteria
Inclusion
- Cohort A:
- Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve
- Patients with a severely calcified aortic valve (Agatston score \> 3000 for men, and \> 1600 for women)
- Patients with small anatomy defined by mean aortic annulus diameter \< 20mm
- Cohort B:
- every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.
Exclusion
- poor CT quality
- previous aortic valve replacement
- Permanent pacemaker at baseline
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04473443
Start Date
August 1 2020
End Date
June 30 2023
Last Update
July 27 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Erasmus Medical Center
Rotterdam, Netherlands, 3015GD