Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.
This study is currently recruiting participants.
Verified December 2012 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Information provided by (Responsible Party):
Bjørn Braathen, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01707927
First received: September 12, 2012
Last updated: December 7, 2012
Last verified: December 2012
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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:
- Pregnant
- Breast feeding
- Aortic valve bigger than 23 mm
- Endocarditis
- 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: | December 7, 2012 |
| 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 May 21, 2013