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

October 12, 2014 updated by: Bjørn Braathen, Oslo University Hospital
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo university hospital, Thoracic departement
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bjørn Braathen, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients operated elektively for aortic valve disease with the need of a biological valve

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Trifecta
Degenerated aortic valve with indication for aortic valve replacement
mosaic Ultra
Need a aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure gradients
Time Frame: 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.
240 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Principal Investigator: Bjørn Braathen, MD Ph.D, OUS thoraxkirurgisk avdeling Ullevål
  • Study Director: Theis Tønnessen, MD Ph.D, OUS thoraxkirurgisk avdeling Ullevål

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

October 15, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 15, 2014

Last Update Submitted That Met QC Criteria

October 12, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/2596/REK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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