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
-
-
-
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
|
Two heart valve designs
|
|
Active Comparator: 2
Valve design 2
|
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
Collaborators
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.