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

Not Applicable

Active, not recruiting

• Conditions: Infections; Pacemaker Complication
• Interventions: Procedure: Partial capsule decortication

• Registration Number: NCT05390216
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-21
• Study First Posted: 2022-05-25
• Study Start: 2022-06-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2026-05-31
• Study Completion: 2030-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1016

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial capsule decortication	Partial capsule decortication	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Rate of all CIED-related infection	Within the first year after the operation	All infections that related to CIED operation.
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 pocket hematoma	Within the first year after the operation	Palpable swelling with fluctuance that extended beyond the device margin but without evidence of infection.

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China