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

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT01707927
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-12
• Last Update Posted: 2014-10-15
• Primary Completion: 2015-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pressure gradients	240 days	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.

Trial Locations

Locations (1)

Oslo university hospital, Thoracic departement; 🇳🇴 Oslo, Norway