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Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 24, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date July 11, 2016
Study Start Date  ICMJE January 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Diagnostic
Condition  ICMJE
  • Aortic Valve Stenosis
  • Heart Valve Disease
Intervention  ICMJE Other: 4-dimensional volume-rendered computed tomography
Study Arms  ICMJE Not Provided
Publications * Dalén M, Sartipy U, Cederlund K, Franco-Cereceda A, Svensson A, Themudo R, Svenarud P, Bacsovics Brolin E. Hypo-Attenuated Leaflet Thickening and Reduced Leaflet Motion in Sutureless Bioprosthetic Aortic Valves. J Am Heart Assoc. 2017 Aug 21;6(8). pii: e005251. doi: 10.1161/JAHA.116.005251.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2016)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2016)
55
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671474
Other Study ID Numbers  ICMJE Perceval thrombosis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Magnus Dalén, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE Not Provided
PRS Account Karolinska University Hospital
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP