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CryoValve SG Pulmonary Human Heart Valve Post Clearance Study (SGPV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CryoLife, Inc.
ClinicalTrials.gov Identifier:
NCT01092442
First received: March 23, 2010
Last updated: December 8, 2015
Last verified: December 2015
Results First Received: November 2, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Pulmonary Valve Stenosis
Pulmonary Valve Insufficiency
Aortic Valve Stenosis
Aortic Valve Insufficiency
Intervention: Procedure: Echocardiogram

  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
Retrospective Patients Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
Prospective Patients Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.

Participant Flow:   Overall Study
    Retrospective Patients     Prospective Patients  
STARTED     80     60  
COMPLETED     80     60  
NOT COMPLETED     0     0  



  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
Retrospective Patients Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
Prospective Patients Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
Total Total of all reporting groups

Baseline Measures
    Retrospective Patients     Prospective Patients     Total  
Number of Participants  
[units: participants]
  80     60     140  
Age  
[units: participants]
     
<=18 years     66     33     99  
Between 18 and 65 years     14     26     40  
>=65 years     0     1     1  
Age  
[units: years]
Mean (Standard Deviation)
  15.8  (14.1)     26.2  (21.1)     20.2  (18.1)  
Gender  
[units: participants]
     
Female     27     16     43  
Male     53     44     97  
Region of Enrollment  
[units: participants]
     
United States     80     60     140  



  Outcome Measures
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1.  Primary:   Hemodynamic Performance   [ Time Frame: Most Recent follow-up (average of 3-6 years post implant) ]

2.  Primary:   Hemodynamic Performance   [ Time Frame: Most Recent Follow-up (average of 4 to 6 years post implant) ]

3.  Primary:   Safety Assessment   [ Time Frame: Since Implant of the Valve to a Maximum of 13.0 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: Scott B. Capps, MS
Organization: CryoLife, Inc.
phone: 800-438-8285
e-mail: brown.carolyn@cryolife.com


Publications:

Responsible Party: CryoLife, Inc.
ClinicalTrials.gov Identifier: NCT01092442     History of Changes
Other Study ID Numbers: CSG801.002-M
Study First Received: March 23, 2010
Results First Received: November 2, 2015
Last Updated: December 8, 2015
Health Authority: United States: Institutional Review Board