Heart Valve Diseases Clinical Trial
Official title:
Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab
Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of transcatheter aortic valve replacement (TAVR)
OVAL (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab) is a
single centre, prospective, proof-of-principle, feasibility study performed in the Academic
Medical Centre (Amsterdam). One hundred consecutive patients with aortic stenosis and
indication to undergo TAVR by the Institution's Heart team are being enrolled in OVAL. All
final aortograms will be performed according to predetermined acquisition protocol and
analysed immediately after the acquisition in the cath-lab. All aortograms will also be
analysed off-line by an independent core laboratory in the Netherlands (Cardialysis,
Rotterdam, The Netherlands).
The primary endpoint of the study is the feasibility of the on-line assessment of
regurgitation (percentage of analysable cases). The secondary endpoint is the reproducibility
of results between the on-line assessment and the off-line analysis by the independent core
laboratory.
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