Aortic Valve Replacement With Trifecta(TM)

Aortic Valve Stenosis Clinical Trial

Official title:

An Observational, Prospective Evaluation of the Trifecta Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475267
• Other study ID #: CS0601
• Status: Completed
• Phase: N/A
• Start date: May 2007
• Est. completion date: January 2012

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: January 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Trifecta aortic heart valve
Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.

Locations

Country	Name	City	State
Canada	QEII Health Sciences Center	Halifax	Nova Scotia
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Hôpital Laval	Québec	Quebec
Canada	University Health Network - Toronto General Hospital	Toronto	Ontario
Canada	University of British Columbia, St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Canada, 

Outcome

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