Aortic Valve Replacement With Trifecta(TM)

Abbott Medical Devices203 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

203

Conditions

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

Interventions

Trifecta aortic heart valveDEVICE

Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

University of British Columbia, St. Paul's Hospital

Vancouver, British Columbia, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Characterize patient NYHA functional classification status.

Time frame: At required follow-up intervals

Characterize the hemodynamic performance of the valve.

Time frame: At required follow-up intervals

Establish adverse event rates.

Time frame: Ongoing

Data from ClinicalTrials.gov

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