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CompletedNCT00377871Updated Jun 2, 2015

Hemodynamic Performance in Stentless Heart Valves

An interventional study of biological heart valve prosthesis in Heart Valve Diseases, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-06-02.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Valve Diseases

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Keywords

  • Stentless
  • Biological
  • aortic
  • heart
  • valve
  • prosthesis
  • artificial
03

In context

Heart Valve Diseases

535 studies on the registry are indexed under Heart Valve Diseases; 173 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 291 interventional studies indexed under Heart Valve Diseases.

Browse Heart Valve Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Stentless valve implantation not possible
  • Contraindications for MRI scan
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    1

    Valve design 1

    Device: biological heart valve prosthesis

  • Active comparator
    2

    Valve design 2

    Device: biological heart valve prosthesis

  • No intervention
    Control

    Healthy control

Interventions

  • Devicebiological heart valve prosthesis

    Two heart valve designs

06

What researchers measure

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

07

Study locations

1 site
  • Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
    Aarhus N, 8200, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00377871
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, LivaNova, Abbott Medical Devices, Raimond and Dagmar Ringgård-Bohn's Foundation, Carl og Ellen Hertz´ Legat, Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond, Jens Anker Andersen Fonden
Responsible party
Sponsor
First posted
Sep 19, 2006
Start date
May 2007
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Jun 2, 2015

Study contacts

Jonas A Funder, MD
principal investigator · Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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