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

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.

Study Overview

• Status: Recruiting
• Conditions: Infections; Pacemaker Complication
• Intervention / Treatment: Procedure: Partial capsule decortication

• Study Type: Interventional
• Enrollment (Anticipated): 1016
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • 180 Fenglin Road
      • Contact: Lei Zhang, MD; Phone Number: 862164041990; Email: zhanglei2423@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Partial capsule decortication	Procedure: Partial capsule decortication; The anterior wall of the capsule was removed during the operation.
NO_INTERVENTION: Without partial capsule decortication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of minor CIED-related infection	Infections that do not meet the definition criteria of major CIED infection.	Within the first year after the operation
Rate of all CIED-related infection	All infections that related to CIED operation.	Within the first year after the operation
Rate of pocket hematoma	Palpable swelling with fluctuance that extended beyond the device margin but without evidence of infection.	Within the first year after the operation
Rate of device dysfunction	All the dysfunction of the generators and leads (including abnormal changes of pacing threshold, sensing, impedance, etc.).	Within the first year after the operation
All-cause mortality	Death regardless of the causes.	Within the first year after the operation

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2022
• Primary Completion (ANTICIPATED): May 31, 2026
• Study Completion (ANTICIPATED): May 31, 2026

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (ACTUAL): May 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Prosthesis-Related Infections
• Other Study ID Numbers: 12901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No