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Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

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ClinicalTrials.gov Identifier: NCT02671474
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Magnus Dalén, Karolinska University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Heart Valve Disease Other: 4-dimensional volume-rendered computed tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Primary Purpose: Diagnostic
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671474


Locations
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Sweden
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Magnus Dalén, MD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02671474    
Other Study ID Numbers: Perceval thrombosis
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction