Pediatric Lead Extractability and Survival Evaluation (PLEASE)
Stopped early · Not applicable
Conditions studied: Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome, Congenital Heart Disease
In brief
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.
Key facts
- Study ID
- NCT00335036
- Run by
- Charles Berul
- People needed
- 748
- Starts
- 2006-06-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2026-03-19
Who can join
Age: 1 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
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).
Where it is running
- Children's Hospital Boston — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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