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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 12, 2014
Last verified: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: October 12, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
EOA

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

ClinicalTrials.gov processed this record on October 21, 2014