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Clinical trial

Randomized Noninferiority Study of an Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients

NCT02809131 is registered in ClinicalTrials.gov with Vanderbilt University Medical Center as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
Randomized Noninferiority Study of an Antibacterial Envelope Alone Versus Envelope Plus Intraoperative Antibacterial Irrigant and Postoperative Antibiotics to Prevent Cardiac Implantable Electronic Device Infections in High-Risk Patients
Lead sponsor
Vanderbilt University Medical Center
Phase
Phase 3
Overall status
Completed
Start date
April 1, 2016
Completion date
September 30, 2021
Enrollment
1,010 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

chronic systolic heart failure, complete heart block, sick sinus syndrome, syncope