UnknownNot Applicable

Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation

Netherlands200 participantsStarted 2020-08-01

Plain-language 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 (Cohort B).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.

What they're measuring

overall device success conform the VARC-2 document

Timeframe: 30 days after TAVI

Trial details

NCT IDNCT04473443

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-02-01

Contact for this trial

Nicolas van Mieghem, MD, PhD

+31107035260 n.vanmieghem@erasmusmc.nl

View on ClinicalTrials.gov More Aortic Valve Stenosis trials