Hemodynamic Performance in Stentless Heart Valves

May 31, 2015 updated by: University of Aarhus

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
turbulence
Time Frame: jan 2010
jan 2010
flow dynamics
Time Frame: jan 2010
jan 2010
aortic root dynamics
Time Frame: jan 2010
jan 2010
Effective orifice area
Time Frame: 2010
2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Abbott Medical Devices
LivaNova
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 31, 2015

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-218/2-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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