NCT00335036 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
Stephenson EA, Batra AS, Knilans TK, Gow RM, Gradaus R, Balaji S, Dubin AM, Rhee EK, Ro PS, Thøgersen 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.

Pediatric Lead Extractability and Survival Evaluation (PLEASE)Study: A Prospective Assessment of Implantable Cardioverter Defibrillator (ICD) Lead Extractability and Survival in Children and Congenital Heart Disease Patients

Details for clinical trial NCT00335036

Clinical trial NCT00335036 - References