Pediatric Lead Extractability and Survival Evaluation (PLEASE)

NCT00335036 | Terminated Results DMC

• 1 other identifier: CHB-05-11-147
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Implantable Cardioverter Defibrillator; Ventricular Arrhythmia; Sudden Cardiac Death; Congenital Heart Disease; Pediatric Electrophysiology

Outcome Measures

Primary Outcomes (2)

• ICD Lead Functionality and Performance by Subtype

  Lead survival

  5 years

• Compare Ease of Lead Extractability by Subtype

  Extraction techniques include simple traction (no locking stylet or sheath) and advanced extraction (locking stylet with a sheath). Compared number of extractions using each technique for single and ePTFE-coated coils.

  5 years

Secondary Outcomes (2)

• Number of Patients With Major Complications

  5 years

• Comparison of Inappropriate Shocks

  5 years

Study Arms (2)

Thin leads

ACTIVE COMPARATOR

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

Device: Thin leads

Gore PTFE-coated

ACTIVE COMPARATOR

ICD lead with PTFE-coated coils

Device: ICD lead implant

Interventions

ICD lead implant DEVICE

Randomization of ICD lead type at implant

Gore PTFE-coated

Thin leads DEVICE

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

Thin leads

Eligibility Criteria

• Age: 1 Year - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients will be eligible for study enrollment at the time of implantation of a new ICD and transvenous ICD lead.
• All patients under the age of 21 years at the time of initial ICD implantation, or those patients with congenital heart disease and an indication for ICD implantation are eligible for participation.

You may not qualify if:

• Patients who have existing ICD leads in place.
• Patients with expected survival less than 1 year.
• Patients who cannot be expected to participate in follow-up visits.
• Patients receiving an epicardial or subcutaneous ICD (without transvenous ICD lead).

Sponsors & Collaborators

• Medtronic: collaborator
• Guidant Corporation: collaborator
• Charles Berul: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• Alexander ME, Cecchin F, Walsh EP, Triedman JK, Bevilacqua LM, Berul CI. Implications of implantable cardioverter defibrillator therapy in congenital heart disease and pediatrics. J Cardiovasc Electrophysiol. 2004 Jan;15(1):72-6. doi: 10.1046/j.1540-8167.2004.03388.x.

  PMID: 15028076 BACKGROUND

• Stephenson EA, Batra AS, Knilans TK, Gow RM, Gradaus R, Balaji S, Dubin AM, Rhee EK, Ro PS, Thogersen AM, Cecchin F, Triedman JK, Walsh EP, Berul CI. A multicenter experience with novel implantable cardioverter defibrillator configurations in the pediatric and congenital heart disease population. J Cardiovasc Electrophysiol. 2006 Jan;17(1):41-6. doi: 10.1111/j.1540-8167.2005.00271.x.

  PMID: 16426398 BACKGROUND

• Cooper JM, Stephenson EA, Berul CI, Walsh EP, Epstein LM. Implantable cardioverter defibrillator lead complications and laser extraction in children and young adults with congenital heart disease: implications for implantation and management. J Cardiovasc Electrophysiol. 2003 Apr;14(4):344-9. doi: 10.1046/j.1540-8167.2003.02500.x.

  PMID: 12741703 BACKGROUND

• Link MS, Hill SL, Cliff DL, Swygman CA, Foote CB, Homoud MK, Wang PJ, Estes NA 3rd, Berul CI. Comparison of frequency of complications of implantable cardioverter-defibrillators in children versus adults. Am J Cardiol. 1999 Jan 15;83(2):263-6, A5-6. doi: 10.1016/s0002-9149(98)00834-0.

  PMID: 10073833 BACKGROUND

• Atallah J, Erickson CC, Cecchin F, Dubin AM, Law IH, Cohen MI, Lapage MJ, Cannon BC, Chun TU, Freedenberg V, Gierdalski M, Berul CI; Pediatric and Congenital Electrophysiology Society (PACES). Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study. Circulation. 2013 Jun 18;127(24):2393-402. doi: 10.1161/CIRCULATIONAHA.112.001120. Epub 2013 May 21.

  PMID: 23694966 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Fibrillation; Cardiomyopathies; Long QT Syndrome; Heart Defects, Congenital; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Arrest; Death, Sudden; Death

Results Point of Contact

• Title: Charles Berul, MD
• Organization: Children's National

cberul@childrensnational.org

202-476-5710

Study Officials

• Charles I Berul, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 8, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 19, 2026
• Results First Posted: July 17, 2025

Record last verified: 2026-03

Locations

US (1)