Status:
ACTIVE_NOT_RECRUITING
Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Pacemaker Complication
Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in...
Eligibility Criteria
Inclusion
- Patient is at least 18 years of age
- Patient is planned to undergo at least one of the following procedures:
- a) Patient has existing CIED (pacemaker, or CRT-P, or ICD, or CRT-D) and is undergoing pulse generator replacement or upgrade with a new generator. b) Patients planned to have leads added, or extracted and added for upgrades.
- Patient is willing to sign and date informed consent
Exclusion
- History of CIED-related infection
- Open the pocket for any reason within the last one year
- Any evidence indicating active infection
- Requirement of long term vascular access for any reason
- Expected survival time is less than one year
- Patients who were pregnant or breastfeeding
- Participation in another study that may confound the results of this study
- Patient is unable to comply with scheduled follow up
Key Trial Info
Start Date :
June 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2030
Estimated Enrollment :
1016 Patients enrolled
Trial Details
Trial ID
NCT05390216
Start Date
June 5 2022
End Date
May 31 2030
Last Update
June 24 2024
Active Locations (1)
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1
180 Fenglin Road
Shanghai, Shanghai Municipality, China, 200032