Status:
COMPLETED
Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)
Lead Sponsor:
Population Health Research Institute
Conditions:
Arrythmias
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk patients undergoing ar...
Detailed Description
Infection can occur after surgery for either a pacemaker or an implantable defibrillation and can have very serious consequences. These infections are common and can be seen in as many as 2-3% of high...
Eligibility Criteria
Inclusion
- \> 18 years
- One of the following planned device procedures:
- ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement or
- Pocket or lead revision or
- System upgrade (insertion or attempted insertion of leads) or
- New cardiac resynchronization therapy device implant (pacemaker or ICD)
Exclusion
- Unable or unwilling to provide written informed consent
- Unable or unwilling to complete the study follow-up schedule
- Life expectancy \< 12 months as per the opinion if the local investigator
- Allergy to or unable to tolerate cefazolin or clindamycin or vancomycin
- Allergy to or unable to tolerate intracavitary bacitracin or gentamicin or cefazolin
- Previously enrolled in this trial
- In another study that would confound the results of this trial
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01002911
Start Date
December 1 2009
End Date
January 1 2012
Last Update
May 16 2013
Active Locations (1)
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1
Institut universitaire de cardiologie et de pneumologie de Quebec
Ste-Foy, Quebec, Canada, G1V 4G5