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

NCT ID: NCT03644784

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Aortic Valve Insufficiency Aortic Valve Regurgitation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Yamaguchi University Hospital

Standardized protocol for assessing aortic regurgitation using videodensitometry

Intervention Type DIAGNOSTIC_TEST

Standardized protocol for assessing aortic regurgitation using videodensitometry

Erasmus Medical Center

Standardized protocol for assessing aortic regurgitation using videodensitometry

Intervention Type DIAGNOSTIC_TEST

Standardized protocol for assessing aortic regurgitation using videodensitometry

Academic Medical Center - Amsterdam

Standardized protocol for assessing aortic regurgitation using videodensitometry

Intervention Type DIAGNOSTIC_TEST

Standardized protocol for assessing aortic regurgitation using videodensitometry

Segeberger Kliniken Gruppe

Standardized protocol for assessing aortic regurgitation using videodensitometry

Intervention Type DIAGNOSTIC_TEST

Standardized protocol for assessing aortic regurgitation using videodensitometry

McGill University - Montreal

Standardized protocol for assessing aortic regurgitation using videodensitometry

Intervention Type DIAGNOSTIC_TEST

Standardized protocol for assessing aortic regurgitation using videodensitometry

Interventions

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Standardized protocol for assessing aortic regurgitation using videodensitometry

Standardized protocol for assessing aortic regurgitation using videodensitometry

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Eligible and undergoing TAVR procedure

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yamaguchi University Hospital

OTHER

Sponsor Role collaborator

Segeberger Kliniken GmbH

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Patrick W. Serruys

Prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick W Serruys, MD, PhD

Role: STUDY_CHAIR

Imperial College London

Rodrigo Modolo, MD

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Yoshinobu Onuma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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McGill University

Montreal, , Canada

Site Status

Segeberger Kliniken

Bad Segeberg, , Germany

Site Status

Yamaguchi University

Yamaguchi, , Japan

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Imperial College

London, , United Kingdom

Site Status

Countries

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Canada Germany Japan Netherlands United Kingdom

References

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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.

Reference Type RESULT
PMID: 31147307 (View on PubMed)

Other Identifiers

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ASSESS-REGURGE

Identifier Type: -

Identifier Source: org_study_id

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