Implantable Defibrillator User — Shock Testing to Unmask RV Lead and GEnerator Malfunction in ICD Patients: the SURGE-ICD Registry
Citation(s)
Bun SS, Duytschaever M, Tavernier R Defibrillation testing can reveal 'concealed' lead fracture. Europace. 2013 Jan;15(1):54. doi: 10.1093/europace/eus173. Epub 2012 Jun 19.
Phan K, Kabunga P, Kilborn MJ, Sy RW Defibrillator Threshold Testing at Generator Replacement: Is it Time to Abandon the Practice? Pacing Clin Electrophysiol. 2015 Jul;38(7):777-81. doi: 10.1111/pace.12630. Epub 2015 Apr 20. Review.
Shah P, Singh G, Chandra S, Schuger CD Failure to deliver therapy by a Riata Lead with internal wire externalization and normal electrical parameters during routine interrogation. J Cardiovasc Electrophysiol. 2013 Jan;24(1):94-6. doi: 10.1111/j.1540-8167.2012.02361.x. Epub 2012 May 21.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
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.
