Aortic Valve Replacement With Trifecta(TM)
An Observational, Prospective Evaluation of the Trifecta Valve
1 other identifier
interventional
203
1 country
5
Brief Summary
The purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2007
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 16, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 4, 2019
February 1, 2019
3.2 years
May 16, 2007
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Interventions
Intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of British Columbia, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 3A7, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Hôpital Laval
Québec, Quebec, GN 4G5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hartzell Schaff, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2007
First Posted
May 21, 2007
Study Start
May 1, 2007
Primary Completion
July 1, 2010
Study Completion
January 1, 2012
Last Updated
February 4, 2019
Record last verified: 2019-02