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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01707927

Enrollment

Registered

2012-10-16

Start date

2012-09-30

Completion date

2022-12-31

Last updated

2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

Keywords

EOA

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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%

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Norway

Contacts

Primary ContactBjørn Braathen, MD Ph.D

uxjrbr@ous-hf.no0047 22118080

Backup ContactTheis Tønnessen, MD Ph.d

uxthto@ous-hf.no0047 22118080

Outcome results