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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01514162
First received: January 17, 2012
Last updated: May 2, 2017
Last verified: March 2017
  Purpose
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

Condition Intervention
Heart Valve Diseases Device: Trifecta valve

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Late Adverse Event Incidence [ Time Frame: 5 years ]

    Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.

    Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]



Secondary Outcome Measures:
  • Characterize Patient NYHA Functional Classification Status [ Time Frame: 5 years ]

    The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

    Class I. Patients with cardiac disease but without resulting limitation of physical activity.

    Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.

    Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

    Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

    The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.


  • Report the Hemodynamic Performance of the Valve [ Time Frame: 5 years ]

    Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.

    Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.

    Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.



Enrollment: 245
Study Start Date: February 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trifecta Valve Group
Subjects implanted with a Trifecta valve.
Device: Trifecta valve
surgical replacement of aortic valve

Detailed Description:
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects implanted with a 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 provides 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
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: 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

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01514162     History of Changes
Other Study ID Numbers: 1003
Study First Received: January 17, 2012
Results First Received: October 14, 2016
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by St. Jude Medical:
Trifecta Valve

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2017