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Hemodynamic Performance in Stentless Heart Valves

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00377871
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : June 2, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Heart Valve Diseases Device: biological heart valve prosthesis

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Performance in Stentless Heart Valves
Study Start Date : May 2007
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377871


Locations
Denmark
Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
LivaNova
St. Jude Medical
Raimond and Dagmar Ringgård-Bohn's Foundation
Carl og Ellen Hertz´ Legat
Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond
Jens Anker Andersen Fonden
Investigators
Principal Investigator: Jonas A Funder, MD Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT00377871     History of Changes
Other Study ID Numbers: 2005-218/2-14
First Posted: September 19, 2006    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: February 2008

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

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