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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial capsule decortication | Experimental |
| |
| Without partial capsule decortication | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial capsule decortication | Procedure | The anterior wall of the capsule was removed during the operation. |
|
| 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 |
| 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Shanghai | Shanghai Municipality | 200032 | China |
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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 |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D002541 | Cerebral Decortication |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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