Back to resultsStent Geometry in Sutureless Bioprosthetic Valves
Primary Purpose
Aortic Valve Stenosis, Heart Valve Diseases
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 (LivaNova) 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
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cardiac CT imaging
Arm Description
Outcomes
Primary Outcome Measures
Regional expansion of valve prosthesis
Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve
Overall expansion of valve prosthesis
Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve
Secondary Outcome Measures
Eccentricity of valve prosthesis
Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)×100
Full Information
NCT ID
NCT03753126
First Posted
November 22, 2018
Last Updated
November 26, 2018
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03753126
Brief Title
Stent Geometry in Sutureless Bioprosthetic Valves
Official Title
Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (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 geometry and hypo-atrenuated leaflet thickening. 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 Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac CT imaging
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
4-dimensional volume-rendered computed tomography
Primary Outcome Measure Information:
Title
Regional expansion of valve prosthesis
Description
Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve
Time Frame
At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Title
Overall expansion of valve prosthesis
Description
Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve
Time Frame
At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Secondary Outcome Measure Information:
Title
Eccentricity of valve prosthesis
Description
Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)×100
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
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Implanted with a sutureless Perceval (LivaNova) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Dalén, MD PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
31950251
Citation
Themudo R, Kastengren M, Bacsovics Brolin E, Cederlund K, Svensson A, Dalen M. Leaflet thickening and stent geometry in sutureless bioprosthetic aortic valves. Heart Vessels. 2020 Jun;35(6):868-875. doi: 10.1007/s00380-020-01553-9. Epub 2020 Jan 16.
Results Reference
derived
Learn more about this trial
Stent Geometry in Sutureless Bioprosthetic Valves
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