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

NCT ID: NCT01707927

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trifecta

Degenerated aortic valve with indication for aortic valve replacement

No interventions assigned to this group

mosaic Ultra

Need a aortic valve replacement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aortic valve disease

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bjørn Braathen

MD. Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bjørn Braathen, MD Ph.D

Role: PRINCIPAL_INVESTIGATOR

OUS Thoraxkirurgisk avdeling Ullevål

Theis Tønnessen, MD Ph.D

Role: STUDY_DIRECTOR

OUS thoraxkirurgisk avdeling Ullevål

Locations

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Oslo university hospital, Thoracic departement

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Bjørn Braathen, MD Ph.D

Role: CONTACT

0047 22118080 ext. 19703

Theis Tønnessen, MD Ph.d

Role: CONTACT

0047 22118080 ext. 15268

Facility Contacts

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Bjørn Braathen, MD. PhD

Role: primary

004722118080

Theis Tønnessen, MD, PhD

Role: backup

004722118080

Other Identifiers

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2011/2596/REK

Identifier Type: -

Identifier Source: org_study_id

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