Stent Geometry in Sutureless Bioprosthetic Valves

Aortic Valve Stenosis Clinical Trial

Official title:

Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753126
• Other study ID #: Perceval Geometry
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Heart Valve Diseases

Intervention

Radiation:
• 4-dimensional volume-rendered computed tomography

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Primary	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	At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
Secondary	Eccentricity of valve prosthesis	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