Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement
NCT ID: NCT05390216
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1016 participants
INTERVENTIONAL
2022-06-05
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Partial capsule decortication
Partial capsule decortication
The anterior wall of the capsule was removed during the operation.
Without partial capsule decortication
No interventions assigned to this group
Interventions
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Partial capsule decortication
The anterior wall of the capsule was removed during the operation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Locations
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180 Fenglin Road
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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12901
Identifier Type: -
Identifier Source: org_study_id
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