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Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities

This study has been withdrawn prior to enrollment.
(Submission converted to 510(k))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411658
First Posted: December 14, 2006
Last Update Posted: April 7, 2015
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:
LifeNet Health
December 13, 2006
December 14, 2006
April 7, 2015
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  • Determination of stenosis
  • Determination of dilation towards aneurysm
  • Serious adverse events attributable to the graft
  • Determination of device structural integrity
  • Determination of calcification of the graft proper
Complete list of historical versions of study NCT00411658 on ClinicalTrials.gov Archive Site
Not Provided
  • Determination of Panel Reactive Antibody (PRA) formation
  • Determination of thromboembolism
  • Determination of bleeding events handled medically
  • Determination of bleeding events handled operatively
  • Determination of infection
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Not Provided
 
Devitalized Non-valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities
Not Provided
Study no longer required
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Interventional
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NA-Study Withdrawn
  • Device: Investigational Device
  • Device: Experimental
  • Other: Cryopreserved
  • Experimental: Investigational Device
    Interventions:
    • Device: Investigational Device
    • Device: Experimental
  • Active Comparator: Cryopreserved
    Intervention: Other: Cryopreserved
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
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Child, Adult, Senior
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00411658
CR06-002
Not Provided
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Not Provided
LifeNet Health
Not Provided
Not Provided
LifeNet Health
April 2015

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