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Clinical Trials/NCT00377871
NCT00377871CompletedNot Applicable

Hemodynamic Performance in Stentless Heart Valves

University of Aarhus2 sites in 1 country15 target enrollmentStarted: May 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
2
Primary Endpoint
turbulence
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
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

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

Outcomes

Primary Outcomes

turbulence

Time Frame: jan 2010

Effective orifice area

Time Frame: 2010

aortic root dynamics

Time Frame: jan 2010

flow dynamics

Time Frame: jan 2010

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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Hemodynamic Performance in Stentless Heart... | Clinical Trial