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

Aortic Valve Stenosis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01707927
• Other study ID #: 2011/2596/REK
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2012
• Last updated: October 12, 2014
• Start date: September 2012
• Est. completion date: December 2022

Study information

• Verified date: October 2014
• Source: Oslo University Hospital
• Contact: Bjørn Braathen, MD Ph.D
• Phone: 0047 22118080
• Email: uxjrbr[@]ous-hf.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2022
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aortic valve disease

Exclusion Criteria:

1. Pregnant

2. Breast feeding

3. Aortic valve bigger than 23 mm

4. Endocarditis

5. EF < 50%

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Locations

Country	Name	City	State
Norway	Oslo university hospital, Thoracic departement	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure gradients	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.	240 days	No