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Completed

NCT Number: NCT03644784

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

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.

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Key information

Conditions

Aortic Valve Insufficiency Aortic Valve Disease Aortic Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McGill University, Montreal, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible and undergoing TAVR procedure

Exclusion criteria

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

Treatment and study plan

Standardized protocol for assessing aortic regurgitation using videodensitometry

Diagnostic Test

Standardized protocol for assessing aortic regurgitation using videodensitometry

Primary outcomes

  1. Feasibility (percentage of the cases considered analyzable) of analysis of aortic regurgitation from aortograms using the videodensitometry technique

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Erasmus Medical Center
  • McGill University
  • Segeberger Kliniken GmbH
  • Yamaguchi University Hospital

Registry information

Acronym: ASSESS-REGURGE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2018
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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