Aortic Valve Replacement With Trifecta(TM) | NCT00475267

Studies
Aortic Valve Replacement With Trifecta(TM)

NCT00475267

Sponsor

Abbott Medical Devices

Status

Completed

Last Update Posted

Feb 4, 2019Actual

Enrollment

203Actual

Phase

Not Applicable

Conditions

Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis

Interventions

Trifecta aortic heart valve

Countries

Canada

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

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jul 2010Actual

Completion Date

Jan 2012Actual

First Submitted Date

May 16, 2007

First Submission Date that Met QC Criteria

May 16, 2007

First Posted Date

May 21, 2007Estimated

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

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.

Detailed Description

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Conditions Module

Conditions

Aortic Valve Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Aortic Valve Stenosis

Keywords

aortic valve
heart valve
tissue valve
bioprosthesis
valve disorder
valve disease
cardiac surgery
aortic valve stenosis
aortic valve regurgitation

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

203Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trifecta aortic heart valve	Device	Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize patient NYHA functional classification status.		At required follow-up intervals
Characterize the hemodynamic performance of the valve.		At required follow-up intervals
Establish adverse event rates.		Ongoing

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
Legal age.
Signed informed consent prior to surgery.
Willing to complete all follow-up requirements.

Exclusion Criteria:

Pregnant or nursing women.
Have already had a valve replaced other than the aortic valve.
Needs another valve replaced.
Cannot return for required follow-up visits.
Have active endocarditis.
Acute preoperative neurological event (such as a stroke).
Renal dialysis.
History of substance abuse within one year, or a prison inmate.
Participating in another study.
Life expectancy less than two years.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hartzell Schaff, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of British Columbia, St. Paul's Hospital		Vancouver	British Columbia	V6Z 1Y6	Canada
QEII Health Sciences Center

Condition Browse Module

MeSH Terms

ID	Term
D001022	Aortic Valve Insufficiency
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