1. Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy (MADIT‐RIT): Background, Rationale, and Clinical Protocol
- Author
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Mary W. Brown, Brian Olshansky, Keith A. Power, N.A. Mark Estes, Arthur J. Moss, Claudio Schuger, W. Jackson Hall, Torsten Kayser, James P. Daubert, David J. Wilber, David S. Cannom, Wojciech Zareba, and Helmut U. Klein
- Subjects
Adult ,Male ,medicine.medical_specialty ,Canada ,Side effect ,medicine.medical_treatment ,Risk Assessment ,Sudden cardiac death ,law.invention ,Randomized controlled trial ,Japan ,law ,Reference Values ,Physiology (medical) ,medicine ,Tachycardia, Supraventricular ,Humans ,Prospective Studies ,Israel ,Intensive care medicine ,Prospective cohort study ,Aged ,Proportional Hazards Models ,Equipment Safety ,Medical Errors ,business.industry ,Proportional hazards model ,Patient Selection ,Arrhythmias, Cardiac ,General Medicine ,Original Articles ,Equipment Design ,Middle Aged ,medicine.disease ,Implantable cardioverter-defibrillator ,Prognosis ,Survival Analysis ,United States ,Defibrillators, Implantable ,Europe ,Death, Sudden, Cardiac ,Treatment Outcome ,Female ,Cardiology and Cardiovascular Medicine ,Risk assessment ,business ,Multicenter Automatic Defibrillator Implantation Trial - Abstract
The implantable cardioverter defibrillator (ICD) is highly effective in reducing mortality due to cardiac arrhythmias in high-risk cardiac patients. However, inappropriate therapies caused predominantly by supraventricular tachyarrhythmias (SVTs) remain a significant side effect of ICD therapy despite medical treatment, affecting 8-40% of patients. The MADIT-RIT is a global, prospective, randomized, nonblinded, three-arm, multicenter clinical investigation to be performed in the Unites States, Europe, Canada, Israel and Japan, and will utilize approximately 90 centers with plan to enroll 1500 patients programmed to three treatment arms. The objective of the MADIT-RIT trial is to determine if dual-chamber ICD or CRT-D devices with high rate cutoff (MADIT-RIT-Arm B) and/or long delay in combination with detection enhancements (MADIT-RIT-Arm C) are associated with fewer patients experiencing inappropriate therapies than standard programming (MADIT-RIT-Arm A) during postimplant follow-up of patients with indication for primary prevention device therapy. This paper describes design and analytic plan for the MADIT-RIT trial.
- Published
- 2012