Completed

An Observational, Prospective Evaluation of the Trifecta Valve

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Aortic Valve Disease+4

+ Aortic Valve Insufficiency

+ Aortic Valve Stenosis

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2007
See protocol details

Summary

Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleAn Observational, Prospective Evaluation of the Trifecta Valve
NCT00475267
Principal SponsorAbbott Medical Devices
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

203 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseAortic Valve InsufficiencyAortic Valve StenosisCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesVentricular Outflow Obstruction

Criteria

4 inclusion criteria required to participate
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.
10 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

University of British Columbia, St. Paul's Hospital

Vancouver, CanadaOpen University of British Columbia, St. Paul's Hospital in Google Maps
Suspended

QEII Health Sciences Center

Halifax, Canada
Suspended

University Health Network - Toronto General Hospital

Toronto, Canada
Suspended

Montreal Heart Institute

Montreal, Canada
Completed5 Study Centers
An Observational, Prospective Evaluation of the Trifecta Valve | PatLynk