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Clinical Evidence

Graph 2002 - 2017

UNTOUCHED Acute Outcomes


The incidence of inappropriate shocks in primary prevention, LVEF ≤ 35% patients will be non-inferior to the rate in transvenous ICD patients with similar programming observed in MADIT-RIT Arms B and C.

Study Design

  • Follow-up for 18 months
  • Device programming with a conditional zone of 200 bpm and a shock zone of 250 bpm
  • Primary endpoint of inappropriate shock-free rate at 18 months
  • Secondary endpoints of all cause shock-free rate at 18 months and system and procedure complications at 30 days

Acute Outcomes

Conversion efficacy and complication-free rates remain high, consistent with historical S-ICD studies.

acute outcomes

UNTOUCHED Chronic Outcomes

Understanding Outcomes With the S-ICD In Primary Patients With Low Ejection Fraction (UNTOUCHED) Trial Primary Results.
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  • Almost all (97.4%) spontaneous ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were successfully converted, showing that S-ICD is effective in treating spontaneous arrhythmias
  • Results also showed that development of a new need for pacing or ATP was low, respectively 0.1% and 0.5%
  • The data shows that 99.7% of patients experienced freedom from complications in the first 30 days after implant, and 98.0% were complication-free
  • After the first year during the mean follow-up period, there were ZERO endovascular infections, systemic infections or electrode failures 
Download the Spanish, German and Italian EFFORTLESS mid-term outcome report.