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Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.

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ClinicalTrials.gov Identifier: NCT01707927
Recruitment Status : Recruiting
First Posted : October 16, 2012
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator.

Condition or disease
Aortic Valve Stenosis

Study Design

Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2012
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Trifecta
Degenerated aortic valve with indication for aortic valve replacement
mosaic Ultra
Need a aortic valve replacement


Outcome Measures

Primary Outcome Measures :
  1. Pressure gradients [ Time Frame: 240 days ]
    Investigators want too look at the effient opening area and pressure gradients of the two valves we are implanting on patients with the same size of the annulus.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients operated elektively for aortic valve disease with the need of a biological valve
Criteria

Inclusion Criteria:

  • Aortic valve disease

Exclusion Criteria:

  1. Pregnant
  2. Breast feeding
  3. Aortic valve bigger than 23 mm
  4. Endocarditis
  5. EF < 50%
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707927


Contacts
Contact: Bjørn Braathen, MD Ph.D 0047 22118080 ext 19703 uxjrbr@ous-hf.no
Contact: Theis Tønnessen, MD Ph.d 0047 22118080 ext 15268 uxthto@ous-hf.no

Locations
Norway
Oslo university hospital, Thoracic departement Recruiting
Oslo, Norway
Contact: Bjørn Braathen, MD. PhD    004722118080    uxjrbr@uus-hf.no   
Contact: Theis Tønnessen, MD, PhD    004722118080    uxthto@uus-hf.no   
Principal Investigator: Bjørn Braathen, MD-PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Bjørn Braathen, MD Ph.D OUS Thoraxkirurgisk avdeling Ullevål
Study Director: Theis Tønnessen, MD Ph.D OUS thoraxkirurgisk avdeling Ullevål
More Information

Responsible Party: Bjørn Braathen, MD. Ph.D, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01707927     History of Changes
Other Study ID Numbers: 2011/2596/REK
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014

Keywords provided by Bjørn Braathen, Oslo University Hospital:
EOA

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction