Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement

Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement: a Multicenter Randomized Controlled Trial

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.

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