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

Aortic Valve Insufficiency Clinical Trial

— ASSESS-REGURGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644784
• Other study ID #: ASSESS-REGURGE
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2019
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: March 31, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible and undergoing TAVR procedure

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Regurgitation

Intervention

Diagnostic Test:
• Standardized protocol for assessing aortic regurgitation using videodensitometry
Standardized protocol for assessing aortic regurgitation using videodensitometry

Locations

Country	Name	City	State
Canada	McGill University	Montréal
Germany	Segeberger Kliniken	Bad Segeberg
Japan	Yamaguchi University	Yamaguchi
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam
United Kingdom	Imperial College	London

Sponsors (6)

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

Countries where clinical trial is conducted

Canada,  Germany,  Japan,  Netherlands,  United Kingdom, 

References & 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 regurg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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