The MADIT-RIT trial is designed to enroll 1500 patients to determine if high rate cutoff or long delay programming in ICD/CRT-D devices reduces inappropriate therapies compared to standard programming.
RCT (n=1,500)
Open-label
Randomized
Yes
Does dual-chamber ICD or CRT-D devices with high rate cutoff and/or long delay reduce inappropriate therapies in patients with indication for primary prevention device therapy?
The MADIT-RIT trial protocol outlines a randomized study to evaluate whether high rate cutoff or long delay programming reduces inappropriate ICD therapies in primary prevention patients.
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.
Schuger et al. (Sun,) conducted a rct in Indication for primary prevention device therapy (n=1,500). Dual-chamber ICD or CRT-D devices with high rate cutoff and/or long delay vs. Standard programming was evaluated on Inappropriate therapies. The MADIT-RIT trial is designed to enroll 1500 patients to determine if high rate cutoff or long delay programming in ICD/CRT-D devices reduces inappropriate therapies compared to standard programming.