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NCT02671474 Clinical Trial

Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

Aortic Valve Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02671474
Other study ID # Perceval thrombosis
Secondary ID
Status Completed
Phase N/A
First received January 24, 2016
Last updated July 7, 2016
Start date January 2016
Est. completion date May 2016

Study information
Verified date July 2016
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial Summary

A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date May 2016
Est. primary completion date March 2016
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• 4-dimensional volume-rendered computed tomography

Locations
Country Name City State
Sweden Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska University Hospital Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduced aortic valve leaflet motion At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
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