Aortic Valve Replacement With Trifecta(TM)

February 1, 2019 updated by: Abbott Medical Devices

An Observational, Prospective Evaluation of the Trifecta Valve

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • University of British Columbia, St. Paul's Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Center
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network - Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
      • Québec, Quebec, Canada, GN 4G5
        • Hôpital Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Hartzell Schaff, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 16, 2007

First Posted (Estimate)

May 21, 2007

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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