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OpenTrials
Completed

NCT Number: NCT00377871

Hemodynamic Performance in Stentless Heart Valves

Hypothesis: Stentless bioprostheses will perform superior to stented bioprostheses in different hemodynamic and biomechanical parameters.

The study will investigate turbulence, flow and aortic root movement in a stentless bioprosthesis and compare it to a stented bioprosthesis.

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Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus

Aarhus N, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 65 years old
  • Submitted for aortic valve surgery
  • No coronary surgery other than LIMA to LAD

Exclusion criteria

  • Stentless valve implantation not possible
  • Contraindications for MRI scan

Treatment and study plan

biological heart valve prosthesis

Device

Two heart valve designs

Primary outcomes

  1. turbulence

    Time frame: jan 2010

  2. flow dynamics

    Time frame: jan 2010

  3. aortic root dynamics

    Time frame: jan 2010

  4. Effective orifice area

    Time frame: 2010

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Abbott Medical Devices
  • Carl og Ellen Hertz´ Legat
  • Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond
  • Jens Anker Andersen Fonden
  • LivaNova
  • Raimond and Dagmar Ringgård-Bohn's Foundation

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 19, 2006
Registry last updated
Jun 2, 2015

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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