Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab

• Conditions: Heart Valve Diseases; Paravalvular Aortic Regurgitation; Aortic Valve Insufficiency; Regurgitation, Aortic

• Registration Number: NCT04047082
• Lead Sponsor: Imperial College London

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-05-15
• Study First Submitted: 2019-06-24
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-05
• Study First Posted: 2019-08-06
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-08
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.

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Exclusion Criteria

• Patients that were not considered by the Institution's heart team as eligible

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of analysis(percentage of cases considered analyzable by videodensitometry - online)	immediately	Feasibility of analysis (percentage of cases considered analyzable by videodensitometry - online). The investigators will assess the percentage of cases that are considered by the investigators as analyzable (i.e., that the investigators are able to perform an on-line analysis of videodensitometry).
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%)	immediately	Since ASSESS-REGURGE has the highest feasibility of analysis with quantitative aortogram, the investigators aim to compare the present feasibility (of OVAL) with the new standard from ASSESS-REGURGE. In other words, the percentage of analyzable cases in the present study will be compared with the percentage of analyzable cases found in ASSESS-REGURGE (95.5% of analyzability).

Secondary Outcome Measures

Name	Time	Method
Comparison of online feasibility with core lab feasibility	immediately	The feasibility of analysis (i.e., if a cases is considered to be analyzable by videodensitometry) will be assessed on-line by the investigators and also assessed by an academic core laboratory. The result of the feasibility of analysis (percentage of analyzable cases) will be compared between the investigators assessment (on-line) and also by the core laboratory.

Trial Locations

Locations (1)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Netherlands