The Multicenter Automatic Defibrillator Implantation Trial – Cardiac Resynchronization Therapy (MADIT-CRT)

• Design
• Patient Population
• Clinical Relevance
• References

Design

Patient Population

• MADIT-CRT is the largest randomized NYHA Class I / II CRT-D trial to date
• 1820 patients
  • Male and female
  • Over 21 years of age
  • NYHA functional Class II, non-ischemic or ischemic cardiomyopathy or
  • NYHA functional Class I, ischemic cardiomyopathy and
  • Left ventricular dysfunction (LVEF ≤ 0.30) and
  • Prolonged intraventricular conduction (QRS duration ≥ 130 ms) and
  • Optimal HF pharmacologic therapy (OPT)
• 110 centers in 14 countries

Clinical Relevance

• To determine whether CRT-D in high-risk* heart failure patients will reduce the combined endpoint of all cause mortality or HF intervention when compared to ICD therapy
• Primary Endpoint: all-cause mortality or heart failure intervention, whichever occurs first
• MADIT-CRT is an important continuation of Boston Scientific’s sponsorship of landmark clinical trials such as MADIT, MADIT II, and COMPANION.  MADIT-CRT may prove that early intervention with CRT can slow the progression of heart failure

* High-risk is defined as QRS width ≥ 130 ms and LVEF ≤ 30%.

References

• MADIT-CRT Study Design

Moss AJ, Brown MW, Cannom DS, et al. Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT): Design and clinical protocol. Ann Noninvasive Electrocardiol. 2005;10(4)(Suppl):34-43.

• MADIT-CRT Study Results

Moss AJ, Cannom DS, Brown MW, et al. Reduction in the Risk of Heart Failure Events with Preventive CRT (serial online). NEJM. Sept 2009 ePublication.