Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED)

Trial Purpose and Description

This study assesses the 18-month incidence of all-cause shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of all-cause S-ICD shocks will be compared to the incidence of all-cause shocks observed in the MADIT RIT study.

Ages: 21 years and older

Gender: Both


Eligibility Criteria

Inclusion Criteria:

  • Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo an implant procedure for an EMBLEM S-ICD (or newer generation BSC S-ICD), including de novo implantation (first ICD) or replacement of a subcutaneous ICD or transvenous ICD
  • Left ventricular ejection fraction ≤ 35%
  • A passing EMBLEM S-ICD (or newer generation BSC S-ICD) screening ECG per current criteria, as listed in the User's Manual; unless patient is currently implanted with a Boston Scientific S-ICD
  • ECG demonstrating sinus rhythm within 30 days of enrollment
  • Patient ≥ 21 years of age willing and capable of giving informed consent

Exclusion Criteria:

  • Patient with a documented history of spontaneous sustained (rate of 160 bpm lasting ≥30 seconds) VT or VF
  • Patient with bradycardia pacing indication
  • Patient with cardiac resynchronization indication
  • Patient with permanent or chronic AF, or cardioversion for AF, within 90 days before enrollment
  • Patient in NYHA Class IV documented in the medical records within 90 days before enrollment
  • Patient with QRS width ≥ 120 ms within 90 days before enrollment
  • Patient with life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
  • Patient receiving dialysis within 180 days before to enrollment
  • Patients unable to give consent in person, including patients unable to read or write
  • Patient who is known to be pregnant or plans to become pregnant over the course of the trial
  • Patient unwilling or unable to cooperate with the protocol


Boston Scientific Corporation

Dates: 10/23/2015 - 06/30/2021

Last Updated: 10/23/2016

Study HIC#: 1509016442

Get Involved

For more information about this study, contact:
Bemen Habashi
+1 203-737-1330
bemen.habashi@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Jude F Clancy

Principal Investigator

Sub-Investigators