Back to resultsValve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
Primary Purpose
Aortic Valve Stenosis, Heart Valve Disease
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
4-dimensional volume-rendered computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Valve Stenosis
Eligibility 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
Sites / Locations
- Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
Outcomes
Primary Outcome Measures
Reduced aortic valve leaflet motion
Secondary Outcome Measures
Full Information
NCT ID
NCT02671474
First Posted
January 24, 2016
Last Updated
July 7, 2016
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02671474
Brief Title
Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Heart Valve Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
4-dimensional volume-rendered computed tomography
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Facility Information:
Facility Name
Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
28862959
Citation
Dalen 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):e005251. doi: 10.1161/JAHA.116.005251.
Results Reference
derived
Learn more about this trial
Valve Leaflet Motion in Sutureless Bioprosthetic Aortic Valves
We'll reach out to this number within 24 hrs