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

Infections Clinical Trial

— STERILE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390216
• Other study ID #: 12901
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1016
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pacemaker Complication
• Prosthesis-Related Infections

Intervention

Procedure:
• Partial capsule decortication
The anterior wall of the capsule was removed during the operation.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of all CIED-related infection	All infections that related to CIED operation.	Within the first year after the operation
Secondary	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
Secondary	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
Secondary	All-cause mortality	Death regardless of the causes.	Within the first year after the operation