Long Term Follow Up Study of the St. Jude Medical Trifecta Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01593917
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : November 20, 2017
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
To collect long term follow up study data of the Trifecta valve in subjects who had the Trifecta valve implanted during the IDE study.

Condition or disease
Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis Aortic Valve Incompetence

Study Type : Observational
Actual Enrollment : 329 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve
Study Start Date : June 2012
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Subjects previously implanted with a Trifecta valve
Subjects enrolled in this clinical study received the Trifecta valve during the investigational study that was conducted to obtain FDA approval

Primary Outcome Measures :
  1. Collecting long term valve related events [ Time Frame: 10 years ]
    The primary objective is to collect long-term study data including long term valve-related events of the Trifecta valve

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects previously implanted with a Trifecta prosthetic valve

Inclusion Criteria:

  • Patient currently has a Trifecta valve that was implanted
  • Patient met eligibility criteria prior to enrollment in the Trifecta IDE study
  • Patient agrees to complete all required follow-up visits
  • Patient provided written informed consent prior to any study related procedure as approved by the governing Institutional Review Board or the Ethics Committee of the investigational site

Exclusion Criteria:

  • Patient is currently participating or planning to participate in any other study unless approved by SJM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01593917

United States, California
Keck School of Medicine of University of Southern California
Los Angeles, California, United States, 90033
United States, Minnesota
Abbott Northwestern
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
United States, North Carolina
Mission Health & Hospitals
Asheville, North Carolina, United States
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-8802
United States, Utah
Intermountain Salt Lake Cardiovascular and Thoracic Surgery
Syracuse, Utah, United States
Canada, British Columbia
University of British Columbia Department of Surgery, Division of Cardiovascular Surgery; St. Paul's Hospital
Vancouver, British Columbia, Canada, V6J 2G7
Institut Universitaire de Cardiologie et Pneumologie de Quebec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
St. Jude Medical
Study Director: Angelic Roach St. Jude Medical

Responsible Party: St. Jude Medical Identifier: NCT01593917     History of Changes
Other Study ID Numbers: 1104
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by St. Jude Medical:
Aortic valve
Heart valve
Tissue valve

Additional relevant MeSH terms:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction