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Tachyarrhythmia Management

Clinical Studies and Outcomes

Several clinical studies, detailed below, have been conducted to evaluate the efficacy of implantable cardioverter defibrillators (ICDs) in treating patients at risk of sudden cardiac arrest. Primary prevention trials compared ICD therapy with antiarrhythmic medication and placebo in heart failure patients and post-MI patients. Secondary prevention trials compared ICD therapy with antiarrhythmic medication for ventricular fibrillation (VF) or sustained ventricular tachycardia (SVT). The MRI ICD trial confirmed the safety and efficacy of an ICD in the MRI environment.

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Evera MRI

Evera MRI Clinical Trial1

The Evera MRI SureScan system is safe and effective in the MRI environment when labeling conditions are met.

  • Prospective, randomized, controlled, multi-center with 275 patients
  • Designed to confirm safety and effectiveness of Evera MRI SureScan ICD System

Results

  • 100% Freedom from MRI-related complications within 30 days post-MRI; no sustained tachyarrhythmias requiring immediate treatment during MRI. (p<0.0001)
  • 100% of MRI subjects did not experience a greater than 0.5 V increase in ventricular pacing capture threshold; Control group 98.2%. (non-inferiority p<0.0001)
  • 99.3% of MRI subjects did not experience a greater than 50% decrease in R-wave amplitude; Control group 98.8%. (non-inferiority p=0.0001)
  • No impact to detection and therapy delivery was observed in 20 induced and 14 spontaneous sustained VT/VF episodes post-MRI.

Reference

1

Gold MR, et al. J Am Coll Cardiol. 2015;65(24):2581-2588.

MADIT

MUSTT

MADIT II

SCD-HeFT

AVID

CIDS

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