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This study has been withdrawn prior to enrollment.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:
Information provided by:
LifeNet Health
ClinicalTrials.gov Identifier:
NCT00411658
First received: December 13, 2006
Last updated: January 16, 2009
Last verified: January 2009

December 13, 2006
January 16, 2009
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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
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  • 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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Devitalized Non-Valved Pulmonary Artery Allograft Implant for the Repair of Congenital Cardiac Abnormalities
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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NA-Study Withdrawn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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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Contact information is only displayed when the study is recruiting subjects
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NCT00411658
CR06-002
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LifeNet Health
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LifeNet Health
January 2009

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