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OpenTrials
Completed

NCT Number: NCT02671474

Valve Leaflet Motion in Sutureless Bioprosthetic Aortic 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 leaflet motion. 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 Disease Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital

Stockholm, Sweden

Who can participate

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

Inclusion criteria

  • Implanted with a sutureless Perceval (Sorin Group) 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

Other

Primary outcomes

  1. Reduced aortic valve leaflet motion

    Time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Jul 11, 2016

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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