Status:
TERMINATED
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
Lead Sponsor:
Elena Gibson
Collaborating Sponsors:
Medtronic
Guidant Corporation
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
1-55 years
Phase:
NA
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 surv...
Detailed Description
The recognition that ICD therapy in children can be life-saving, as well as the development of smaller devices and leads, are resulting in increased ICD implantation in the pediatric and young adult p...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
748 Patients enrolled
Trial Details
Trial ID
NCT00335036
Start Date
June 1 2006
End Date
January 1 2009
Last Update
July 17 2025
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115