Post-Approval Study Protocol 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:
NCT01514162
First received: January 17, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who have had the Trifecta valve implanted during the IDE study.


Condition
Subjects Who Were Previously Implanted With a Trifecta Valve.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Primary Endpoint [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Report late adverse event rates


Secondary Outcome Measures:
  • Secondary Endpoint [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To report subject NYHA functional classification status

  • Secondary Endpoint [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To report the hemodynamic performance of the valve, as per echocardiography


Estimated Enrollment: 300
Study Start Date: February 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Trifecta Valve Group
Subjects who were previously implanted with the Trifecta valve.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects who were previously implanted with the Trifecta valve.

Criteria

Inclusion Criteria:

  • Subjects who were previously implanted with the Trifecta valve at one of the US sites of the IDE study.
  • Subject met eligibility criteria of IDE study
  • Subject agrees to complete study follow-up visits
  • Subject provided written informed consent

Exclusion Criteria:

  • Subject currently participating in another device or drug study
  • Subject unable or unwilling to return for study follow-up visits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514162

Locations
United States, Minnesota
Abbott Northwestern Hospital Cardiac Surgical Associates
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt Heart Institute
Nashville, Tennessee, United States, 37232
United States, Utah
Intermountain Heart & Lung Surgical Associates
Murray, Utah, United States, 84157
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01514162     History of Changes
Other Study ID Numbers: 1003
Study First Received: January 17, 2012
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Medical:
Trifecta Valve

ClinicalTrials.gov processed this record on April 17, 2014