title: Multicenter automatic defibrillator implantation trial: reduce inappropriate therapy (MADIT-RIT): background, rationale, and clinical protocol.
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.
authors: Department of Electrophysiology, Henry Ford Hospital, Detroit, MI 48202, USA. cschuge1@hfhs.org
authors: Claudio
authors: C
authors: Schuger
authors: James P
authors: JP
authors: Daubert
authors: Mary W
authors: MW
authors: Brown
authors: David
authors: D
authors: Cannom
authors: N A Mark
authors: NA
authors: Estes
authors: W Jackson
authors: WJ
authors: Hall
authors: Torsten
authors: T
authors: Kayser
authors: Helmut
authors: H
authors: Klein
authors: Brian
authors: B
authors: Olshansky
authors: Keith A
authors: KA
authors: Power
authors: David
authors: D
authors: Wilber
authors: Wojciech
authors: W
authors: Zareba
authors: Arthur J
authors: AJ
authors: Moss
mesh_terms: D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D002170:Canada; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000706:statistics & numerical data*; D004867:Equipment Design; D004869:Equipment Safety; D005060:Europe; D005260:Female; D006801:Humans; D007557:Israel; D007564:Japan; D008297:Male; D019300:Medical Errors / Q000517:prevention & control*; D008875:Middle Aged; D018579:Patient Selection; D011379:Prognosis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D016019:Survival Analysis; D013617:Tachycardia, Supraventricular / Q000209:etiology* / Q000401:mortality; D016896:Treatment Outcome; D014481:United States