Infections, Pacemaker Complication
Conditions
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 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.
Interventions
PROCEDUREPartial capsule decortication
The anterior wall of the capsule was removed during the operation.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of minor CIED-related infection | Within the first year after the operation | Infections that do not meet the definition criteria of major CIED infection. |
| Rate of all CIED-related infection | Within the first year after the operation | All infections that related to CIED operation. |
| Rate of pocket hematoma | Within the first year after the operation | Palpable swelling with fluctuance that extended beyond the device margin but without evidence of infection. |
| Rate of device dysfunction | Within the first year after the operation | All the dysfunction of the generators and leads (including abnormal changes of pacing threshold, sensing, impedance, etc.). |
| All-cause mortality | Within the first year after the operation | Death regardless of the causes. |
Countries
China
Outcome results
None listed