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Hemodynamic Performance in Stentless Heart Valves

Hemodynamic Performance in Stentless Heart Valves

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00377871
Enrollment
15
Registered
2006-09-19
Start date
2007-05-31
Completion date
2010-01-31
Last updated
2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Keywords

Stentless, Biological, aortic, heart, valve, prosthesis, artificial

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.

Interventions

DEVICEbiological heart valve prosthesis

Two heart valve designs

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
turbulencejan 2010
flow dynamicsjan 2010
aortic root dynamicsjan 2010
Effective orifice area2010

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026