Aortic Valve Replacement With Trifecta(TM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aortic Valve Replacement With Trifecta(TM)

NCT00475709

Aortic Valve Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence +1 more

COMPLETED NA

An Observational, Prospective Evaluation of the Trifecta™ Valve

NCT00727181

Aortic Valve Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence +1 more

COMPLETED NA

Trifecta™ Long Term Follow-Up (LTFU) Study

NCT01593917

Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis +1 more

COMPLETED

Trifecta™ GT Post Market Clinical Follow-up

NCT03016169

Aortic Valve Disease Aortic Valve Disorder

COMPLETED NA

Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

NCT01514162

Heart Valve Diseases

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trifecta aortic heart valve

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No