Partial capsule decortication: The anterior wall of the capsule was removed during the operation.
Study 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 patients with CIED replacement. This multicenter, prospective, single-blinded, randomized controlled trial is to confirm the impact of partial capsule decortication on device-related infection in patients receiving CIED replacement.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Rate of major CIED-related infection — Within the first year after the operation Infections that resulted in CIED system removal, an invasive CIED procedure (e.g., pocket revision without removal), treatment with long-term antibiotic therapy (if the patient was not a candidate for system removal) with infection recurrence after discontinuation of antibiotic therapy, or death.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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