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

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03644784
• Collaborator: Yamaguchi University Hospital (Other), Segeberger Kliniken GmbH (Other), McGill University (Other), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), Erasmus Medical Center (Other)
• Enrollment: 354
• Locations: 6
• Actual Duration (Months): 18.9
• Patients Per Site: 59
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Insufficiency; Aortic Valve Regurgitation	Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry

Study Design

• Study Type: Observational
• Actual Enrollment: 354 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Protocoled Quantitative Assessment of Aortic Regurgitation Using Videodensitometry in a Multicontinental Trial in Rotterdam, Montreal, Yamaguchi, Segeberg, Amsterdam.
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Mar 1, 2019
• Actual Study Completion Date: Mar 31, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eligible and undergoing TAVR procedure

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McGill University	Montréal		Canada
2	Segeberger Kliniken	Bad Segeberg		Germany
3	Yamaguchi University	Yamaguchi		Japan
4	Academic Medical Center	Amsterdam		Netherlands
5	Erasmus Medical Center	Rotterdam		Netherlands
6	Imperial College	London		United Kingdom	3012 KM

Sponsors and Collaborators

• Imperial College London
• Yamaguchi University Hospital
• Segeberger Kliniken GmbH
• McGill University
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Erasmus Medical Center

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patrick W. Serruys, Prof. dr., Imperial College London
• ClinicalTrials.gov Identifier: NCT03644784
• Other Study ID Numbers: ASSESS-REGURGE
• First Posted: Aug 23, 2018
• Last Update Posted: Aug 7, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Insufficiency

Study Results

No Results Posted as of Aug 7, 2019