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Hemodynamic Performance in Stentless Heart Valves

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Aarhus University Hospital
Sorin Group
St. Jude Medical
Raimond og Dagmar Ringgård-Bohn´s Fond
Carl og Ellen Hertz´ Legat
Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond
Kirsten Anthonius´ Mindelegat
Jens Anker Andersen Fonden
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00377871
First received: September 18, 2006
Last updated: February 21, 2008
Last verified: February 2008
History of Changes

September 18, 2006
February 21, 2008
May 2007
January 2010   (final data collection date for primary outcome measure)
  • turbulence [ Time Frame: jan 2010 ] [ Designated as safety issue: No ]
  • flow dynamics [ Time Frame: jan 2010 ] [ Designated as safety issue: No ]
  • aortic root dynamics [ Time Frame: jan 2010 ] [ Designated as safety issue: No ]
  • Effective orifice area [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • turbulence
  • flow dynamics
  • aortic root dynamics
  • Effective orifice area
Complete list of historical versions of study NCT00377871 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Hemodynamic Performance in Stentless Heart Valves
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Valve Diseases
Device: biological heart valve prosthesis
Two heart valve designs
  • Active Comparator: 1
    Valve design 1
    Intervention: Device: biological heart valve prosthesis
  • Active Comparator: 2
    Valve design 2
    Intervention: Device: biological heart valve prosthesis
  • No Intervention: Control
    Healthy control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00377871
2005-218/2-14
No
Jonas Funder, Hjerte-lunge-karkirurgisk afd. T, Århus Universitetshospital, Skejby
University of Aarhus
  • Aarhus University Hospital
  • Sorin Group
  • St. Jude Medical
  • Raimond og Dagmar Ringgård-Bohn´s Fond
  • Carl og Ellen Hertz´ Legat
  • Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond
  • Kirsten Anthonius´ Mindelegat
  • Jens Anker Andersen Fonden
Principal Investigator: Jonas A Funder, MD Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
University of Aarhus
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP