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Hemodynamic Performance in Stentless Heart Valves

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
biological heart valve prosthesis
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Stentless, Biological, aortic, heart, valve, prosthesis, artificial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

1

2

Control

Arm Description

Valve design 1

Valve design 2

Healthy control

Outcomes

Primary Outcome Measures

turbulence
flow dynamics
aortic root dynamics
Effective orifice area

Secondary Outcome Measures

Full Information

First Posted
September 18, 2006
Last Updated
May 31, 2015
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
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1. Study Identification

Unique Protocol Identification Number
NCT00377871
Brief Title
Hemodynamic Performance in Stentless Heart Valves
Official Title
Hemodynamic Performance in Stentless Heart Valves
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
Stentless, Biological, aortic, heart, valve, prosthesis, artificial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Valve design 1
Arm Title
2
Arm Type
Active Comparator
Arm Description
Valve design 2
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy control
Intervention Type
Device
Intervention Name(s)
biological heart valve prosthesis
Intervention Description
Two heart valve designs
Primary Outcome Measure Information:
Title
turbulence
Time Frame
jan 2010
Title
flow dynamics
Time Frame
jan 2010
Title
aortic root dynamics
Time Frame
jan 2010
Title
Effective orifice area
Time Frame
2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas A Funder, MD
Organizational Affiliation
Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hjerte-lunge-karkirurgisk afdeling T, Skejby Sygehus
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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Hemodynamic Performance in Stentless Heart Valves

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