Cardiology Clinical Trials

UNTOUCHED

ClinicalTrials.gov identifier: NCT02433379

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

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.

Who may be eligible to participate?
Subjects 21 and older with ischemic or non-ischemic heart disease who meet current guidelines for ICD therapy and intends to undergo an implant procedure for an EMBLEM S-ICD (or newer generation BSC S-ICD).

Investigator: Edward Kim, MD

For More Information: Shalom Kilcup 425.899.5369 SEKilcup@evergreeenhealth.com