Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab (OVAL)
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About
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)
Full description
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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Inclusion criteria
- Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.
Exclusion criteria
- Patients that were not considered by the Institution's heart team as eligible
Trial contacts and locations
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Central trial contact
Patrick W Serruys, MD, PhD; Yoshinobu Onuma, MD, PhD
Data sourced from clinicaltrials.gov
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