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Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00636987
First received: March 10, 2008
Last updated: April 26, 2017
Last verified: September 2015
Results First Received: October 14, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Aortic Valve Insufficiency
Aortic Valve Regurgitation
Aortic Valve Stenosis
Aortic Valve Incompetence
Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Stenosis
Mitral Valve Incompetence
Intervention: Device: Biocor and Biocor Supra valves

  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
Implanted With Biocor or Biocor Supra Valves Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve

Participant Flow:   Overall Study
    Implanted With Biocor or Biocor Supra Valves
STARTED   297 
COMPLETED   108 
NOT COMPLETED   189 
Death                44 
Explanted                13 
Lost to Follow-up                63 
5 year visit window not complete                69 



  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.
No text entered.

Reporting Groups
  Description
Implanted With Biocor or Biocor Supra Valves Biocor and Biocor Supra valves: Replacement for a diseased, damaged, malformed aortic or mitral heart valve

Baseline Measures
   Implanted With Biocor or Biocor Supra Valves 
Overall Participants Analyzed 
[Units: Participants]
 297 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.2  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      123  41.4% 
Male      174  58.6% 
Region of Enrollment 
[Units: Participants]
 
United States   297 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 5 Years ]

2.  Primary:   Characterize Patient NYHA Functional Classification Status   [ Time Frame: 5 year ]

3.  Primary:   Characterize the Hemodynamic Performance of the Valve   [ Time Frame: 5 Year ]


  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: Sr. Clinical Manager
Organization: St Jude Medical
phone: 6517566803
e-mail: jjohnson101@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00636987     History of Changes
Other Study ID Numbers: 0505
Study First Received: March 10, 2008
Results First Received: October 14, 2016
Last Updated: April 26, 2017