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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
  Purpose

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.


Condition Intervention
Heart Valve Diseases
 Device: biological heart valve prosthesis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemodynamic Performance in Stentless Heart Valves

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: May 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Valve design 1
 Device: biological heart valve prosthesis
Two heart valve designs
Active Comparator: 2
Valve design 2
 Device: biological heart valve prosthesis
Two heart valve designs
No Intervention: Control
Healthy control

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377871

Locations
Denmark
Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
Aarhus N, Denmark, 8200
Sponsors and Collaborators
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
Investigators
Principal Investigator: Jonas A Funder, MD Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
  More Information

No publications provided

Responsible Party: Jonas Funder, Hjerte-lunge-karkirurgisk afd. T, Århus Universitetshospital, Skejby
ClinicalTrials.gov Identifier: NCT00377871     History of Changes
Other Study ID Numbers: 2005-218/2-14
Study First Received: September 18, 2006
Last Updated: February 21, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
Stentless
Biological
aortic
heart
 valve
prosthesis
artificial

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013