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

University of Oslo (UIO)

Status: Unknown

Conditions: Aortic Valve Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT01707927

2011/2596/REK

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aortic valve disease

Exclusion criteria

1. Pregnant
2. Breast feeding
3. Aortic valve bigger than 23 mm
4. Endocarditis
5. EF < 50%

Trial design

70 participants in 2 patient groups

Trifecta

Description:

Degenerated aortic valve with indication for aortic valve replacement

mosaic Ultra

Description:

Need a aortic valve replacement