| Registry | NCT03644784, acronym ASSESS-REGURGE |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 354 (Actual) |
| Sponsor | Imperial College London (Other); collaborators: Yamaguchi University Hospital, Segeberger Kliniken GmbH, McGill University, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center |
| Conditions | Aortic Valve Insufficiency, Aortic Valve Regurgitation |
| Interventions | Standardized protocol for assessing aortic regurgitation using videodensitometry (Diagnostic test) |
| Dates | start 2017-09-01, primary completion 2019-03-01, completion 2019-03-31, first posted 2018-08-23, last updated 2019-08-07 |
| Locations | 6 sites in Canada, Germany, Japan, Netherlands, United Kingdom |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Eligible and undergoing TAVR procedure Exclusion Criteria: * Considered not eligible for TAVR procedure by the local Heart Team
| Facility | City | Country | Status |
|---|---|---|---|
| McGill University | Montreal | Canada | |
| Segeberger Kliniken | Bad Segeberg | Germany | |
| Yamaguchi University | Yamaguchi | Japan | |
| Academic Medical Center | Amsterdam | Netherlands | |
| Erasmus Medical Center | Rotterdam | Netherlands | |
| Imperial College | London | United Kingdom |