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

Study Overview
=================
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.

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

Conditions
-----------------
Pacemaker Complication, Infections

Intervention / Treatment
-----------------
* Procedure: Partial capsule decortication


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial capsule decortication<br> | Procedure: Partial capsule decortication<br>* The anterior wall of the capsule was removed during the operation.<br>|
| No Intervention: Without partial capsule decortication<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |