Browse by author
Lookup NU author(s): Dr Sushma Saksena
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
There are a number of novel ways in which implantable cardioverter defibrillator (ICD) endpoints can be used in clinical trials to evaluate antiarrhythmic drugs. The advances in ICD technology (storage, retrieval, and accurate interpretation of ICD electrograms) expand the potential to include the use of an ICD endpoint as a clinical surrogate for sudden death. The ICD also provides the necessary safety net to test new drugs. The frequent need for antiarrhythmic drugs in patients already fitted with an ICD (e.g., for atrial fibrillation) necessitates knowledge of the drugs' effect an defibrillator threshold. There are interpretative problems and challenges associated with all types of ICD trials, A particular difficult issue is the degree to which the results of data on antiarrhythmic drug efficacy and safety acquired in the context of an ICD endpoint trial might be extrapolated to patient populations in which the device is not used. These and other challenging issues are discussed, with the goal of enhancing the design and interpretation of clinical trials featuring ICD endpoints.
Author(s): Saksena S; Pratt CM; Camm AJ; Bigger JT; Breithardt G; Campbell RWF; Epstein AE; Kappenberger LJ; Kuck KH; Pocock S; Waldo AL
Publication type: Conference Proceedings (inc. Abstract)
Publication status: Published
Conference Name: Cardio-Renal Drugs Advisory Board Meeting of the Food-and-Drug-Administration
Year of Conference: 1999
Publisher: Wiley-Blackwell Publishing, Inc.
Library holdings: Search Newcastle University Library for this item
Series Title: Journal of Cardiovascular Electrophysiology