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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01593917
First received: May 4, 2012
Last updated: April 26, 2017
Last verified: October 2016
  Purpose
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
Aortic Valve Insufficiency Aortic Valve Regurgitation Aortic Valve Stenosis Aortic Valve Incompetence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Follow Up Study of the St. Jude Medical Trifecta™ Valve

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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


Enrollment: 329
Study Start Date: June 2012
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593917

Locations
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
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
Canada
Institut Universitaire de Cardiologie et Pneumologie de Quebec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Angie Roach St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01593917     History of Changes
Other Study ID Numbers: 1104
Study First Received: May 4, 2012
Last Updated: April 26, 2017

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

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

ClinicalTrials.gov processed this record on June 27, 2017