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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514162
First Posted: January 20, 2012
Last Update Posted: May 31, 2017
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.
Information provided by (Responsible Party):
St. Jude Medical
January 17, 2012
January 20, 2012
October 14, 2016
May 31, 2017
May 31, 2017
February 2012
October 2014   (Final data collection date for primary outcome measure)
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]

Primary Endpoint [ Time Frame: 5 years ]
Report late adverse event rates
Complete list of historical versions of study NCT01514162 on ClinicalTrials.gov Archive Site
  • 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.

  • Secondary Endpoint [ Time Frame: 5 years ]
    To report subject NYHA functional classification status
  • Secondary Endpoint [ Time Frame: 5 years ]
    To report the hemodynamic performance of the valve, as per echocardiography
Not Provided
Not Provided
 
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve
To further evaluate the long term clinical safety and effectiveness of the Trifecta valve
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Valve Diseases
Device: Trifecta valve
surgical replacement of aortic valve
Experimental: Trifecta Valve Group
Subjects implanted with a Trifecta valve.
Intervention: Device: Trifecta valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
October 2014
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01514162
1003
No
Not Provided
Plan to Share IPD: No
St. Jude Medical
St. Jude Medical
Not Provided
Not Provided
St. Jude Medical
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP