Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
597 participants
OBSERVATIONAL
2020-04-22
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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CanGaroo Envelope
Patients who received a CanGaroo Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
CanGaroo Envelope
CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
TYRX Envelope
Patients who received a TYRX Envelope with their Cardiac Implantable Electronic Device (CIED) implantation.
TYRX Envelope
TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation
No Envelope
Patients who had their Cardiac Implantable Electronic Device (CIED) implanted with no envelope.
No interventions assigned to this group
Interventions
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CanGaroo Envelope
CanGaroo Envelope with Cardiac Implantable Electronic Device (CIED) implantation
TYRX Envelope
TYRX Envelope with Cardiac Implantable Electronic Device (CIED) implantation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any patient that had a CIED implanted prior to March 27, 2017
ALL
No
Sponsors
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Elutia Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jerome Riebman, MD
Role: STUDY_DIRECTOR
Aziyo Biologicgs, Inc.
Locations
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Piedmont Athens Electrophysiology
Athens, Georgia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CPR-2212
Identifier Type: -
Identifier Source: org_study_id
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