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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03644784
Acronym
ASSESS-REGURGE
Enrollment
354
Registered
2018-08-23
Start date
2017-09-01
Completion date
2019-03-31
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Insufficiency, Aortic Valve Regurgitation

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.

Interventions

DIAGNOSTIC_TESTStandardized protocol for assessing aortic regurgitation using videodensitometry

Standardized protocol for assessing aortic regurgitation using videodensitometry

Sponsors

Yamaguchi University Hospital
CollaboratorOTHER
Segeberger Kliniken GmbH
CollaboratorOTHER
McGill University
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Eligible and undergoing TAVR procedure

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Feasibility (percentage of the cases considered analyzable) of analysis of aortic regurgitation from aortograms using the videodensitometry technique1 yearMeasurement 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.

Countries

Canada, Germany, Japan, Netherlands, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026