TerminatedNot Applicable

Pediatric Lead Extractability and Survival Evaluation (PLEASE)

Stopped: Lead was recalled and manufacturing halted

United States748 participantsStarted 2006-06

Plain-language 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.

Who can participate

Age range1 Year – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

What they're measuring

ICD Lead Functionality and Performance by Subtype

Timeframe: 5 years

Compare Ease of Lead Extractability by Subtype

Timeframe: 5 years

Trial details

NCT IDNCT00335036

SponsorCharles Berul

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01

Results submitted2019-04-01