Comparison of Two Biological Aortic Valves. Mosaic Ultra... | NCT01707927

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

NCT01707927

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Oct 15, 2014Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Aortic Valve Stenosis

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2015Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Oct 15, 2012

First Posted Date

Oct 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2014

Last Update Posted Date

Oct 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trifecta		Degenerated aortic valve with indication for aortic valve replacement
mosaic Ultra		Need a aortic valve replacement

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aortic valve disease

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bjørn Braathen, MD Ph.D	Contact	0047 22118080	19703	uxjrbr@ous-hf.no
Theis Tønnessen, MD Ph.d	Contact	0047 22118080	15268	uxthto@ous-hf.no

Overall Officials

Name	Affiliation	Role
Bjørn Braathen, MD Ph.D	OUS Thoraxkirurgisk avdeling Ullevål	Principal Investigator
Theis Tønnessen, MD Ph.D	OUS thoraxkirurgisk avdeling Ullevål	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo university hospital, Thoracic departement	Recruiting	Oslo			Norway

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided