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Clinical Investigation Of The Mitroflow Aortic Pericardial Heart Valve

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT00630916
First received: February 28, 2008
Last updated: September 20, 2011
Last verified: September 2011
History of Changes
Results First Received: July 8, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Valve Diseases
Intervention: Device: Mitroflow Aortic Heart 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
Mitroflow Aortic Pericardial Valve Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.

Participant Flow:   Overall Study
    Mitroflow Aortic Pericardial Valve  
STARTED     756 [1]
Study Cohort     699 [2]
COMPLETED     546 [3]
NOT COMPLETED     210  
Death                 110  
Explant                 8  
Lost to Follow-up                 5  
Withdrawal by Subject                 30  
Protocol Violation                 7  
Physician Decision                 47  
Lack of Efficacy                 3  
[1] Total patients enrolled (i.e. consented) to participate in the study.
[2] Enrolled but did not receive device via physician decision, protocol violation, or lack of efficacy.
[3] The number of patients that were active (i.e. not drop out) at the end of the study.



  Baseline Characteristics
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Reporting Groups
  Description
Mitroflow Aortic Pericardial Valve Patients implanted with the Mitroflow Aortic valve for treatment of aortic valve disease or dysfunction per the inclusion criteria of the protocol.

Baseline Measures
    Mitroflow Aortic Pericardial Valve  
Number of Participants  
[units: participants]
 		  699  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     96  
>=65 years     603  
Age  
[units: years]
Mean ± Standard Deviation 		  74.3  ± 8.4  
Gender  
[units: participants]
 		 
Female     302  
Male     397  
Region of Enrollment  
[units: participants]
 		 
United States     556  
Canada     143  



  Outcome Measures
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1.  Primary:   Incidence Rate of Adverse Events and Mortality for the Mitroflow Aortic Heart Valve Repair   [ Time Frame: Late postoperative ]
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2.  Primary:   Mean Gradient   [ Time Frame: 12 months ]
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3.  Primary:   Effective Orifice Area   [ Time Frame: 12 months ]
  Show Outcome Measure 3

4.  Secondary:   Aortic Valve Regurgitation   [ Time Frame: 12 months ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Director of Clinical and Medical Affairs
Organization: Sorin Group USA
phone: 512-435-3602
e-mail: barbara.mathews@sorin.com


Publications:


Responsible Party: Sorin Group USA, Inc.
ClinicalTrials.gov Identifier: NCT00630916     History of Changes
Other Study ID Numbers: SYNPCR-01
Study First Received: February 28, 2008
Results First Received: July 8, 2011
Last Updated: September 20, 2011
Health Authority: United States: Food and Drug Administration