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

What is the purpose of this trial?

The primary objective is to assess the 18-month incidence of shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) programmed with zone cutoffs at 200 bpm and 250 bmp and: - an indication for implantation of a defibrillator for primary prevention of sudden cardiac death; - a left ventricular ejection fraction ≤ 35%. The 18-month incidence rate will be compared to an Objective Performance Criteria derived from transvenous ICDs programmed to minimize shocks in the MADIT RIT study. The secondary objective is to assess perioperative complications. Device and procedure related complications at 6 months and implant success rate at 3 months will be assessed to fulfill Post Market Clinical Follow-up (PMCF) requirements.


Participation Guidelines

Ages: 21 years and older

Gender: Both


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
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