Multicenter automatic defibrillator implantation trial: reduce inappropriate therapy (MADIT-RIT): background, rationale, and clinical protocol.
Journal Article (Journal Article;Multicenter Study)
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.
Full Text
Duke Authors
Cited Authors
- Schuger, C; Daubert, JP; Brown, MW; Cannom, D; Estes, NAM; Hall, WJ; Kayser, T; Klein, H; Olshansky, B; Power, KA; Wilber, D; Zareba, W; Moss, AJ
Published Date
- July 2012
Published In
Volume / Issue
- 17 / 3
Start / End Page
- 176 - 185
PubMed ID
- 22816536
Pubmed Central ID
- PMC6932441
Electronic International Standard Serial Number (EISSN)
- 1542-474X
Digital Object Identifier (DOI)
- 10.1111/j.1542-474X.2012.00531.x
Language
- eng
Conference Location
- United States