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

This study is currently recruiting participants.
Verified February 2014 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Bjørn Braathen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01707927
First received: September 12, 2012
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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
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)
Groups/Cohorts
Trifecta
Degenerated aortic valve with indication for aortic valve replacement
mosaic Ultra
Need a aortic valve replacement

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bjørn Braathen, MD. Ph.D, Oslo University Hospital
ClinicalTrials.gov 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:
EOA

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

ClinicalTrials.gov processed this record on April 17, 2014