Multicenter Automatic Defibrillator Implantation Trial: Reduce Inappropriate Therapy (MADIT-RIT): Background, Rationale, and Clinical Protocol

Authors


  • Drs. Schuger and Daubert functioned as coprimary authors.

  • MADIT-RIT is sponsored by a Research Grant to The University of Rochester Medical Center from Cardiac Pacemakers, Inc, DBA-Boston Scientific Cardiac Rhythm Management (CRM), 4100 Hamline Ave. N., St. Paul, MN 55112, Tel: 1800 CARDIAC.

  • Disclosures: Claudio Schuger: Claudio Schuger receives research support from Boston Scientific, St. Jude, Medtronic, Biosense-Webster; and honoraria for advisory board participation from Premier. James Daubert receives research support from Boston Scientific, St. Jude, Medtronic, Biosense-Webster; institutional fellowship support from Boston Scientific, St. Jude, Medtronic, Biosense-Webster and Bard; and honoraria for advisory board participation or lectures from Biosense-Webster, Sanofi-Aventis, Boston Scientific, St. Jude, Premier and Sorin Medical. Mary Brown, Jackson Hall and Helmut Klein receives research support from University of Rochester Medical Center. David Cannom and Brian Olshansky receives research support from The Hospital of the Good Samaritan. N.A. Mark Estes III and David Wilber receives research support from New England Medical Center.

  • Wojciech Zareba received research support from Boston Scientific

  • Arthur J. Moss receives research support from Boston Scientific and honoraria for lectures from Boston Scientific, Medtronic, and St. Jude.

Claudio Schuger, M.D., Henry Ford Hospital, Room M322, 2799 West Grand Blvd, Detroit, MI 48202. E-mail: cschuge1@hfhs.org

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.

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