Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.

Completed

• Conditions: Aortic Valve Regurgitation; Aortic Valve Insufficiency
• Interventions: Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry

• Registration Number: NCT03644784
• Lead Sponsor: Imperial College London

Brief Summary

The ASSESS-REGURGE is a multicenter, multicontinental registry on protocoled aortographic image acquisition after implantation of a transcatheter aortic valve. After the implementation of the acquisition protocol, each participating site will use the standardized approach for their center in order to identify if the images are considered analyzable via videodensitometry quantitative assessment of aortic regurgitation.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• Eligible and undergoing TAVR procedure

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Exclusion Criteria

• Considered not eligible for TAVR procedure by the local Heart Team

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Yamaguchi University Hospital	Standardized protocol for assessing aortic regurgitation using videodensitometry	-
McGill University - Montreal	Standardized protocol for assessing aortic regurgitation using videodensitometry	-
Erasmus Medical Center	Standardized protocol for assessing aortic regurgitation using videodensitometry	-
Segeberger Kliniken Gruppe	Standardized protocol for assessing aortic regurgitation using videodensitometry	-
Academic Medical Center - Amsterdam	Standardized protocol for assessing aortic regurgitation using videodensitometry	-

Primary Outcome Measures

Name	Time	Method
Feasibility (percentage of the cases considered analyzable) of analysis of aortic regurgitation from aortograms using the videodensitometry technique	1 year	Measurement of feasibility, i.e. the percentage of the number of cases, out of the entire sample size that are considered to be analyzable for quantitative aortic regurgitation assessment using videodensitometry after the implementation of the acquisition protocol. Since the analyzability of the aortic regurgitation from the aortograms depends in some acquisition factors, we will assess the feasibility of analysis after implantation of acquisition protocols.

Trial Locations

Locations (6)

Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Yamaguchi University; 🇯🇵 Yamaguchi, Japan

McGill University; 🇨🇦 Montréal, Canada

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Imperial College; 🇬🇧 London, United Kingdom