Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement: a Multicenter Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pacemaker Complication
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 1016
- Locations
- 1
- Primary Endpoint
- Rate of major CIED-related infection
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of major CIED-related infection
Time Frame: 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 Outcomes
- Rate of device dysfunction(Within the first year after the operation)
- All-cause mortality(Within the first year after the operation)
- Rate of all CIED-related infection(Within the first year after the operation)
- Rate of minor CIED-related infection(Within the first year after the operation)
- Rate of pocket hematoma(Within the first year after the operation)