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

This study is currently recruiting participants.
Verified February 2014 by Oslo University Hospital
Information provided by (Responsible Party):
Bjørn Braathen, Oslo University Hospital Identifier:
First received: September 12, 2012
Last updated: February 28, 2014
Last verified: February 2014

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.

Aortic Valve Stenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Pressure gradients [ Time Frame: 240 days ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Degenerated aortic valve with indication for aortic valve replacement
mosaic Ultra
Need a aortic valve replacement


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients operated elektively for aortic valve disease with the need of a biological valve


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
Please refer to this study by its identifier: NCT01707927

Contact: Bjørn Braathen, MD Ph.D 0047 22118080 ext 19703
Contact: Theis Tønnessen, MD Ph.d 0047 22118080 ext 15268

Oslo university hospital, Thoracic departement Recruiting
Oslo, Norway
Contact: Bjørn Braathen, MD. PhD    004722118080   
Contact: Theis Tønnessen, MD, PhD    004722118080   
Principal Investigator: Bjørn Braathen, MD-PhD         
Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Bjørn Braathen, MD Ph.D OUS Thoraxkirurgisk avdeling Ullevål
Study Director: Theis Tønnessen, MD Ph.D OUS thoraxkirurgisk avdeling Ullevål
  More Information

No publications provided

Responsible Party: Bjørn Braathen, MD. Ph.D, Oslo University Hospital Identifier: NCT01707927     History of Changes
Other Study ID Numbers: 2011/2596/REK
Study First Received: September 12, 2012
Last Updated: February 28, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction processed this record on April 17, 2014