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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Valve Insufficiency, Aortic Valve Regurgitation

Intervention / Treatment
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* Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible and undergoing TAVR procedure Exclusion Criteria: Considered not eligible for TAVR procedure by the local Heart Team

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Yamaguchi University Hospital<br> | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry<br>* Standardized protocol for assessing aortic regurgitation using videodensitometry<br>|
| Erasmus Medical Center<br> | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry<br>* Standardized protocol for assessing aortic regurgitation using videodensitometry<br>|
| Academic Medical Center - Amsterdam<br> | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry<br>* Standardized protocol for assessing aortic regurgitation using videodensitometry<br>|
| Segeberger Kliniken Gruppe<br> | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry<br>* Standardized protocol for assessing aortic regurgitation using videodensitometry<br>|
| McGill University - Montreal<br> | Diagnostic Test: Standardized protocol for assessing aortic regurgitation using videodensitometry<br>* Standardized protocol for assessing aortic regurgitation using videodensitometry<br>|

What is the study measuring?
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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 |