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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
Results First Submitted: October 14, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Heart Valve Diseases
Intervention: Device: Trifecta valve

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Trifecta Valve Group Subjects implanted with a Trifecta valve.

Participant Flow:   Overall Study
    Trifecta Valve Group
STARTED   245 
COMPLETED   160 
NOT COMPLETED   85 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Trifecta Valve Group Subjects implanted with a Trifecta valve.

Baseline Measures
   Trifecta Valve Group 
Overall Participants Analyzed 
[Units: Participants]
 245 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      45  18.4% 
>=65 years      200  81.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 72  (8.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      73  29.8% 
Male      172  70.2% 
Region of Enrollment 
[Units: Participants]
 
United States   245 


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

2.  Secondary:   Characterize Patient NYHA Functional Classification Status   [ Time Frame: 5 years ]

3.  Secondary:   Report the Hemodynamic Performance of the Valve   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jennifer Johnson
Organization: St Jude Medical
phone: 6517566803
e-mail: jjohnson101@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01514162     History of Changes
Other Study ID Numbers: 1003
First Submitted: January 17, 2012
First Posted: January 20, 2012
Results First Submitted: October 14, 2016
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017