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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 July 2016 |
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Main ID: |
NCT02671474 |
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Date of registration:
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24/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
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Scientific title:
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Date of first enrolment:
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January 2016 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02671474 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Implanted with a sutureless Perceval (Sorin Group) sutureless bioprosthetic aortic
valve at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016
- Provide written informed consent
Exclusion Criteria:
- Contraindication for CT with intravenous contrast injection
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Heart Valve Disease
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Aortic Valve Stenosis
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Intervention(s)
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Other: 4-dimensional volume-rendered computed tomography
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Primary Outcome(s)
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Reduced aortic valve leaflet motion
[Time Frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement]
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Secondary ID(s)
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Perceval thrombosis
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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