Hemodynamic Performance in Stentless Heart Valves

NCT ID: NCT00377871

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Valve design 1

Group Type ACTIVE_COMPARATOR

biological heart valve prosthesis

Intervention Type DEVICE

Two heart valve designs

2

Valve design 2

Group Type ACTIVE_COMPARATOR

biological heart valve prosthesis

Intervention Type DEVICE

Two heart valve designs

Control

Healthy control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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biological heart valve prosthesis

Two heart valve designs

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

LivaNova

INDUSTRY

Sponsor Role collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Raimond and Dagmar Ringgård-Bohn's Foundation

OTHER

Sponsor Role collaborator

Carl og Ellen Hertz´ Legat

UNKNOWN

Sponsor Role collaborator

Direktør Kurt Bønnelycke og hustru Grete Bønnelyckes Fond

UNKNOWN

Sponsor Role collaborator

Jens Anker Andersen Fonden

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonas A Funder, MD

Role: PRINCIPAL_INVESTIGATOR

Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus

Locations

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Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus

Aarhus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2005-218/2-14

Identifier Type: -

Identifier Source: org_study_id

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