Protocol Revision History

  1. June 7, 2015 – Draft
  2. August 10, 2015 – Draft
  3. November 15, 2016 – updated randomization (2 strata per site)
  4. April 9, 2017 – Suggestion of statistical part by Dr. Saran (mostly wording).Change the inclusion criteria to include patients with ICD with at least 1 appropriate shock in the last 5 years
  5. July 10, 2017 revised follow-up to +/- 2 months
  6. July 13, 2017 revised 1st followup to 3 month with Ajmaline or alternative agent outlined in protocol.  Subsequent visits with be every 3 months +/- 2 months.
  7. July 18, 2017 Inclusion criteria modified…patients with ICD less than 5 yrs.