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Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab

NCT ID: NCT04047082

Last Updated: 2019-08-08

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2019-09-30

Brief Summary

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Following the high feasibility of analyses by core laboratory with videodensitometry determined in the ASSESS-REGURGE Registry, this is an early clinical feasibility study of online videodensitometric assessment of aortograms to quantitate aortic regurgitation (AR) in the cath lab, specifically in the setting of transcatheter aortic valve replacement (TAVR)

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Detailed Description

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OVAL (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab) is a single centre, prospective, proof-of-principle, feasibility study performed in the Academic Medical Centre (Amsterdam). One hundred consecutive patients with aortic stenosis and indication to undergo TAVR by the Institution's Heart team are being enrolled in OVAL. All final aortograms will be performed according to predetermined acquisition protocol and analysed immediately after the acquisition in the cath-lab. All aortograms will also be analysed off-line by an independent core laboratory in the Netherlands (Cardialysis, Rotterdam, The Netherlands).

The primary endpoint of the study is the feasibility of the on-line assessment of regurgitation (percentage of analysable cases). The secondary endpoint is the reproducibility of results between the on-line assessment and the off-line analysis by the independent core laboratory.

Conditions

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Aortic Valve Insufficiency Heart Valve Diseases Regurgitation, Aortic Paravalvular Aortic Regurgitation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Quantitative aortogram (videodensitometry)

Patients that performed TAVR will have their aortogram analysed in the cath-lab by videodensitometry (quantitative aortogram)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients with indication to undergo TAVR by the Institution's Heart Team.

Exclusion Criteria

* Patients that were not considered by the Institution's heart team as eligible
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam University Medical Center

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Patrick W. Serruys

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick W Serruys, MD, PhD

Role: STUDY_CHAIR

Imperial College London

Rodrigo Modolo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Center

Robbert de Winter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Center

Locations

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Amsterdam University Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Patrick W Serruys, MD, PhD

Role: CONTACT

[email protected]
+31102062828

Yoshinobu Onuma, MD, PhD

Role: CONTACT

[email protected]
+31102062828

Facility Contacts

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Patrick W Serruys, Prof. dr.

Role: primary

[email protected]
+31102062828

References

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Modolo R, van Mourik M, El Bouziani A, Kawashima H, Rosseel L, Abdelghani M, Aben JP, Slots T, Sahyoun C, Baan J, Henriques JPS, Koch KT, Vis M, Soliman O, Onuma Y, Wykrzykowska J, de Winter R, Serruys PW. Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study. JACC Cardiovasc Interv. 2021 Mar 8;14(5):531-538. doi: 10.1016/j.jcin.2020.11.014. Epub 2021 Feb 10.

Reference Type DERIVED
PMID: 33582086 (View on PubMed)

Other Identifiers

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OVAL

Identifier Type: -

Identifier Source: org_study_id

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