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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,016
The anterior wall of the capsule was removed during the operation.
180 Fenglin Road
Shanghai, Shanghai Municipality, China
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.
Time frame: Within the first year after the operation
Rate of minor CIED-related infection
Infections that do not meet the definition criteria of major CIED infection.
Time frame: Within the first year after the operation
Rate of all CIED-related infection
All infections that related to CIED operation.
Time frame: 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.
Time frame: 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.).
Time frame: Within the first year after the operation
All-cause mortality
Death regardless of the causes.
Time frame: Within the first year after the operation
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