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

NCT05390216 | Active Not Recruiting

• 1 other identifier: 12901
• Study Type: interventional
• Target: 1,016
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker Complication; Infections

Outcome Measures

Primary Outcomes (1)

• Rate of major CIED-related infection

  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.

  Within the first year after the operation

Secondary Outcomes (5)

• Rate of minor CIED-related infection

  Within the first year after the operation

• Rate of all CIED-related infection

  Within the first year after the operation

• Rate of pocket hematoma

  Within the first year after the operation

• Rate of device dysfunction

  Within the first year after the operation

• All-cause mortality

  Within the first year after the operation

Study Arms (2)

Partial capsule decortication

EXPERIMENTAL

Procedure: Partial capsule decortication

Without partial capsule decortication

NO INTERVENTION

Interventions

Partial capsule decortication PROCEDURE

The anterior wall of the capsule was removed during the operation.

Partial capsule decortication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Infections

Interventions

Cerebral Decortication

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 25, 2022
• Study Start: June 5, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2030
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)