Aortic Valve Replacement With Trifecta(TM)

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Regurgitation, Aortic Valve; Aortic Valve Incompetence; Aortic Valve Insufficiency

• Registration Number: NCT00475267
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-16
• Study First Submitted QC: 2007-05-16
• Study First Posted: 2007-05-21
• Primary Completion: 2010-07
• Study Completion: 2012-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (5)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

Hôpital Laval; 🇨🇦 Québec, Quebec, Canada

University of British Columbia, St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

QEII Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada