- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03753126
Stent Geometry in Sutureless Bioprosthetic Valves
November 26, 2018 updated by: Magnus Dalén, Karolinska University Hospital
Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Stockholm, Sweden
- Karolinska University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cardiac CT imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Regional expansion of valve prosthesis
Time Frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
|
Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve
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At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
|
Overall expansion of valve prosthesis
Time Frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
|
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
|
At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eccentricity of valve prosthesis
Time Frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
|
Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)×100
|
At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Magnus Dalén, MD PhD, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
November 1, 2018
Study Completion (Actual)
November 1, 2018
Study Registration Dates
First Submitted
November 22, 2018
First Submitted That Met QC Criteria
November 22, 2018
First Posted (Actual)
November 26, 2018
Study Record Updates
Last Update Posted (Actual)
November 28, 2018
Last Update Submitted That Met QC Criteria
November 26, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Perceval Geometry
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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