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

NCT03644784 — Completed, 354 participants, Imperial College London

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RegistryNCT03644784, acronym ASSESS-REGURGE
StatusCompleted
Study typeObservational
Enrollment354 (Actual)
SponsorImperial College London (Other); collaborators: Yamaguchi University Hospital, Segeberger Kliniken GmbH, McGill University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center
ConditionsAortic Valve Insufficiency, Aortic Valve Regurgitation
InterventionsStandardized protocol for assessing aortic regurgitation using videodensitometry (Diagnostic test)
Datesstart 2017-09-01, primary completion 2019-03-01, completion 2019-03-31, first posted 2018-08-23, last updated 2019-08-07
Locations6 sites in Canada, Germany, Japan, Netherlands, United Kingdom

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Yamaguchi University HospitalDiagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry
Erasmus Medical CenterDiagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry
Academic Medical Center - AmsterdamDiagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry
Segeberger Kliniken GruppeDiagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry
McGill University - MontrealDiagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry
  • Standardized protocol for assessing aortic regurgitation using videodensitometry (Diagnostic test): Standardized protocol for assessing aortic regurgitation using videodensitometry

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Eligible and undergoing TAVR procedure

Exclusion Criteria:

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

+Locations (6)

FacilityCityCountryStatus
McGill UniversityMontrealCanada
Segeberger KlinikenBad SegebergGermany
Yamaguchi UniversityYamaguchiJapan
Academic Medical CenterAmsterdamNetherlands
Erasmus Medical CenterRotterdamNetherlands
Imperial CollegeLondonUnited Kingdom

+Publications

  • Results publication: Modolo R, Chang CC, Tateishi H, Miyazaki Y, Pighi M, Abdelghani M, Roos MA, Wolff Q, Wykrzykowska JJ, de Winter RJ, Piazza N, Richardt G, Abdel-Wahab M, Soliman OII, Onuma Y, Van Mieghem NM, Serruys PW. Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry. EuroIntervention. 2019 Aug 29;15(5):420-426. doi: 10.4244/EIJ-D-19-00362. PMID 31147307

+Investigators

My Notes