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NCT Number: NCT05390216

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pacemaker Complication Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partial capsule decortication

Procedure

The anterior wall of the capsule was removed during the operation.

Primary outcomes

  1. Rate of major CIED-related infection

    Time frame: Within the first year after the operation

    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 outcomes

  1. Rate of minor CIED-related infection

    Time frame: Within the first year after the operation

    Infections that do not meet the definition criteria of major CIED infection.

  2. Rate of all CIED-related infection

    Time frame: Within the first year after the operation

    All infections that related to CIED operation.

  3. Rate of pocket hematoma

    Time frame: Within the first year after the operation

    Palpable swelling with fluctuance that extended beyond the device margin but without evidence of infection.

  4. Rate of device dysfunction

    Time frame: Within the first year after the operation

    All the dysfunction of the generators and leads (including abnormal changes of pacing threshold, sensing, impedance, etc.).

  5. All-cause mortality

    Time frame: Within the first year after the operation

    Death regardless of the causes.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Acronym: STERILE

Important dates

Study start
2022
Primary completion
2026
Study completion
2030
First posted
May 25, 2022
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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