Back to resultsImpact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement (STERILE)
Primary Purpose
Pacemaker Complication, Infections
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Partial capsule decortication
Sponsored by
About this trial
This is an interventional treatment trial for Pacemaker Complication
Eligibility Criteria
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
Sites / Locations
- 180 Fenglin RoadRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Partial capsule decortication
Without partial capsule decortication
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of minor CIED-related infection
Infections that do not meet the definition criteria of major CIED infection.
Rate of all CIED-related infection
All infections that related to CIED operation.
Rate of pocket hematoma
Palpable swelling with fluctuance that extended beyond the device margin but without evidence of infection.
Rate of device dysfunction
All the dysfunction of the generators and leads (including abnormal changes of pacing threshold, sensing, impedance, etc.).
All-cause mortality
Death regardless of the causes.
Full Information
NCT ID
NCT05390216
First Posted
May 18, 2022
Last Updated
June 30, 2022
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05390216
Brief Title
Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2022 (Actual)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pacemaker Complication, Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1016 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partial capsule decortication
Arm Type
Experimental
Arm Title
Without partial capsule decortication
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Partial capsule decortication
Intervention Description
The anterior wall of the capsule was removed during the operation.
Primary Outcome Measure Information:
Title
Rate of major CIED-related infection
Description
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.
Time Frame
Within the first year after the operation
Secondary Outcome Measure Information:
Title
Rate of minor CIED-related infection
Description
Infections that do not meet the definition criteria of major CIED infection.
Time Frame
Within the first year after the operation
Title
Rate of all CIED-related infection
Description
All infections that related to CIED operation.
Time Frame
Within the first year after the operation
Title
Rate of pocket hematoma
Description
Palpable swelling with fluctuance that extended beyond the device margin but without evidence of infection.
Time Frame
Within the first year after the operation
Title
Rate of device dysfunction
Description
All the dysfunction of the generators and leads (including abnormal changes of pacing threshold, sensing, impedance, etc.).
Time Frame
Within the first year after the operation
Title
All-cause mortality
Description
Death regardless of the causes.
Time Frame
Within the first year after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Zhang, MD
Phone
862164041990
Email
zhanglei2423@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement
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