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Completed

NCT Number: NCT03753126

Stent Geometry in Sutureless Bioprosthetic 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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4-dimensional volume-rendered computed tomography

Radiation

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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