Stent Geometry in Sutureless Bioprosthetic Valves

Karolinska University Hospital

Status: Completed

Conditions: Heart Valve Diseases; Aortic Valve Stenosis

Treatments: Radiation: 4-dimensional volume-rendered computed tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT03753126

Perceval Geometry

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

47 participants in 1 patient group

Cardiac CT imaging

Other group

Treatment:

Radiation: 4-dimensional volume-rendered computed tomography