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Pediatric Lead Extractability and Survival Evaluation (PLEASE)

NCT00335036 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 748

Last updated 2026-03-19

Study results available
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Summary

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.

Conditions

  • Ventricular Tachycardia
  • Ventricular Fibrillation
  • Cardiomyopathy
  • Long QT Syndrome
  • Congenital Heart Disease

Interventions

DEVICE

ICD lead implant

Randomization of ICD lead type at implant

DEVICE

Thin leads

Thin (less than or equal to 7 French introducer) isodiametric ICD leads

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Guidant Corporation

    collaborator INDUSTRY

  • Charles Berul

    lead OTHER

Principal Investigators

  • Charles I Berul, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00335036 on ClinicalTrials.gov