Clinical trial NCT04047082: Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab
Official title: Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Insufficiency
Heart Valve Diseases
Regurgitation, Aortic
Paravalvular Aortic Regurgitation
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Amsterdam University Medical Center
First posted: 2019-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe symptomatic aortic stenosis, requiring valve replacement.

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online)
timeFrame: immediately
measure: Comparison with feasibility of ASSESS-REGURGE ( to compare the percentage of analyzable cases with the percentage of the current standard found in ASSESS-REGURGE - 95.5%)
timeFrame: immediately
Secondary outcomes:
measure: Comparison of online feasibility with core lab feasibility
timeFrame: immediately
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
Study officials:
affiliation: Imperial College London
name: Patrick W Serruys, MD, PhD
role: STUDY_CHAIR
affiliation: Amsterdam University Medical Center
name: Rodrigo Modolo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam University Medical Center
name: Robbert de Winter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modolo R, van Mourik M, El Bouziani A, Kawashima H, Rosseel L, Abdelghani M, Aben JP, Slots T, Sahyoun C, Baan J, Henriques JPS, Koch KT, Vis M, Soliman O, Onuma Y, Wykrzykowska J, de Winter R, Serruys PW. Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study. JACC Cardiovasc Interv. 2021 Mar 8;14(5):531-538. doi: 10.1016/j.jcin.2020.11.014. Epub 2021 Feb 10.