Pediatric Lead Extractability and Survival Evaluation (PLEASE)

StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Lead sponsor: Elena Gibson to Charles Berulv9
  2. Lead sponsor: Charles Berul to Elena Gibsonv8 Show 4 more changesShow less
    • Results first posted: Jul 17, 2025
    • Enrollment target: 55 to 748
    • Primary endpoints revised (2)
    • Secondary endpoints: 4 to 2
  3. Re-verified, no change to tracked fieldsv7
  4. Phase: Phase 4 to Not applicable
    • Lead sponsor: Boston Children's Hospital to Charles Berul
    • Interventions: ICD lead implant (Device) to ICD lead implant (Device), Thin leads (Device)
    v6
  5. Trial status: Recruiting to Terminated Sponsor's reason: Lead was recalled and manufacturing haltedv5 Show 4 more changesShow less
    • Enrollment target: estimated 300 to confirmed 55
    • Primary completion date: Jan 2009
    • Study completion date changed from estimate of Jun 2011 to Jan 2009
    • Site details revised
Show 3 earlier versionsHide 3 earlier versions
  1. Eligibility criteria revised
    • Secondary endpoints revised (4)
    • Primary endpoints revised (2)
    v4
  2. Primary endpoints: 3 to 2
    • Interventions: Implantable Cardioverter Defibrillator Lead (Device) to ICD lead implant (Device)
    • Secondary endpoints: 3 to 4
    • Study arms: 0 to 2
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease. ICD lead survival in this patient group is particularly suboptimal, and lead extraction is technically difficult and carries a substantial morbidity risk. Recently, improved ICD lead designs have been released and are currently being utilized in patients. The main aim of the study is to determine if either type of lead performs better in terms of implantation electrical characteristics, long-term survival without breaking, and ease of extractability.
Trial Details
NCT Number NCT00335036
Lead Sponsor Charles Berul
Collaborators: Medtronic, Guidant Corporation
Conditions
(from sponsor)		 Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome, Congenital Heart Disease
Related terms Cardiomyopathies, Death, Sudden, Cardiac, Heart Defects, Congenital, Long QT Syndrome, Tachycardia, Ventricular, Ventricular Fibrillation
Enrollment 748 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov