Stent Geometry in Sutureless Bioprosthetic Valves

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Heart Valve Diseases
• Interventions: Radiation: 4-dimensional volume-rendered computed tomography

• Registration Number: NCT03753126
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2018-11
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-26
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cardiac CT imaging	4-dimensional volume-rendered computed tomography	-

Primary Outcome Measures

Name	Time	Method
Regional expansion of valve prosthesis	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
Overall expansion of valve prosthesis	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

Secondary Outcome Measures

Name	Time	Method
Eccentricity of valve prosthesis	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

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden