Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam. (ASSESS-REGURGE)

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Insufficiency; Aortic Valve Regurgitation
• Intervention / Treatment: Diagnostic test: Standardized protocol for assessing aortic regurgitation using videodensitometry

• Study Type: Observational
• Enrollment (Actual): 354

Contacts and Locations

Study Locations

• Canada
  • Montréal, Canada
    • McGill University
• Germany
  • Bad Segeberg, Germany
    • Segeberger Kliniken
• Japan
  • Yamaguchi, Japan
    • Yamaguchi University
• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Center
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• United Kingdom
  • London, United Kingdom, 3012 KM
    • Imperial College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Eligible and undergoing TAVR procedure

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Yamaguchi University Hospital	Diagnostic test: Standardized protocol for assessing aortic regurgitation using videodensitometry; Standardized protocol for assessing aortic regurgitation using videodensitometry
Erasmus Medical Center	Diagnostic test: Standardized protocol for assessing aortic regurgitation using videodensitometry; Standardized protocol for assessing aortic regurgitation using videodensitometry
Academic Medical Center - Amsterdam	Diagnostic test: Standardized protocol for assessing aortic regurgitation using videodensitometry; Standardized protocol for assessing aortic regurgitation using videodensitometry
Segeberger Kliniken Gruppe	Diagnostic test: Standardized protocol for assessing aortic regurgitation using videodensitometry; Standardized protocol for assessing aortic regurgitation using videodensitometry
McGill University - Montreal	Diagnostic test: Standardized protocol for assessing aortic regurgitation using videodensitometry; Standardized protocol for assessing aortic regurgitation using videodensitometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: McGill University; Erasmus Medical Center; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Segeberger Kliniken GmbH; Yamaguchi University Hospital
• Investigators: Study Chair: Patrick W Serruys, MD, PhD, Imperial College London; Principal Investigator: Rodrigo Modolo, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Principal Investigator: Yoshinobu Onuma, MD, PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: ASSESS-REGURGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No