Active — Not RecruitingNot Applicable

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

China1,016 participantsStarted 2022-06-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of major CIED-related infection

Timeframe: Within the first year after the operation

Trial details

NCT IDNCT05390216

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

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