NCT03644784

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
5 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

March 1, 2018

Last Update Submit

August 5, 2019

Conditions

Aortic Valve InsufficiencyAortic Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 year

Study Arms (5)

Yamaguchi University Hospital

Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry

Erasmus Medical Center

Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry

Academic Medical Center - Amsterdam

Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry

Segeberger Kliniken Gruppe

Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry

McGill University - Montreal

Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry

Interventions

Standardized protocol for assessing aortic regurgitation using videodensitometryDIAGNOSTIC_TEST

Standardized protocol for assessing aortic regurgitation using videodensitometry

Academic Medical Center - AmsterdamErasmus Medical CenterMcGill University - MontrealSegeberger Kliniken GruppeYamaguchi University Hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with aortic regurgitation that are undergoing TAVR in the 5 centers

You may qualify if:

  • Eligible and undergoing TAVR procedure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

McGill University

Montreal, Canada

Location

Segeberger Kliniken

Bad Segeberg, Germany

Location

Yamaguchi University

Yamaguchi, Japan

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Imperial College

London, 3012 KM, United Kingdom

Location

Related Publications (1)

  • 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: 31147307RESULT

MeSH Terms

Conditions

Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Patrick W Serruys, MD, PhD

    Imperial College London

    STUDY CHAIR

  • Rodrigo Modolo, MD

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

    PRINCIPAL INVESTIGATOR

  • Yoshinobu Onuma, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

March 1, 2018

First Posted

August 23, 2018

Study Start

September 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 31, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)GB(1)JP(1)NL(2)CA(1)