Brief Title
Stent Geometry in Sutureless Bioprosthetic Valves
Official Title
Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves
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.
Study Type
Interventional
Primary Outcome
Regional expansion of valve prosthesis
Secondary Outcome
Eccentricity of valve prosthesis
Condition
Aortic Valve Stenosis
Intervention
4-dimensional volume-rendered computed tomography
Study Arms / Comparison Groups
Cardiac CT imaging
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
47
Start Date
January 2016
Completion Date
November 2018
Primary Completion Date
November 2018
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Magnus Dalén, MD PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT03753126
Organization ID
Perceval Geometry
Responsible Party
Principal Investigator
Study Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
Study Sponsor
Magnus Dalén, MD PhD, Principal Investigator, Karolinska Institutet
Verification Date
November 2018