NCT01707927

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

3 years

First QC Date

September 12, 2012

Last Update Submit

October 12, 2014

Conditions

Aortic Valve Stenosis

Keywords

EOA

Outcome Measures

Primary Outcomes (1)

  • Pressure gradients

    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

Study Arms (2)

Trifecta

Degenerated aortic valve with indication for aortic valve replacement

mosaic Ultra

Need a aortic valve replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Aortic valve disease

You may not qualify if:

  • Pregnant
  • Breast feeding
  • Aortic valve bigger than 23 mm
  • Endocarditis
  • EF \< 50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo university hospital, Thoracic departement

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Bjørn Braathen, MD Ph.D

    OUS Thoraxkirurgisk avdeling Ullevål

    PRINCIPAL INVESTIGATOR

  • Theis Tønnessen, MD Ph.D

    OUS thoraxkirurgisk avdeling Ullevål

    STUDY DIRECTOR

Central Study Contacts

Bjørn Braathen, MD Ph.D

CONTACT

0047 22118080uxjrbr@ous-hf.no

Theis Tønnessen, MD Ph.d

CONTACT

0047 22118080uxthto@ous-hf.no

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Ph.D

Study Record Dates

First Submitted

September 12, 2012

First Posted

October 16, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

December 1, 2022

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

NO(1)