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

Completed · Not applicable

Conditions studied: Ventricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output

In brief

This study assesses the 18-month incidence of inappropriate 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 inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.

Key facts

Study ID

NCT02433379

Run by

Boston Scientific Corporation

People needed

1173

Starts

2015-06-09

Expected to finish

2019-12-06

Last updated by the study team

2025-03-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient with ischemic or non-ischemic heart disease who meets current guidelines for ICD therapy and intends to undergo a de novo implant procedure for an EMBLEM™ S-ICD (or newer generation BSC S-ICD)
• Left ventricular ejection fraction ≤ 35%
• A passing EMBLEM™ S-ICD (or newer generation BSC S-ICD) screening ECG
• Patient ≥ 21 years of age willing and capable of giving informed consent
• Patient willing and capable of complying with follow-up visits

You may not qualify if…

• Patient with a history of spontaneous sustained VT or VF
• Patient with bradycardia pacing indication
• Patient eligible and scheduled for cardiac resynchronization implant
• Patient with a previous S-ICD or a previous transvenous pulse generator (pacemaker or defibrillator)
• Patient in NYHA Class IV documented in the medical records 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 hemodialysis 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
• Participation in concurrent clinical study without prior approval from Boston Scientific
• Medical status (e.g., hemodynamic conditions ) of the patient doesn't allow programming devices with a conditional shock zone at 200 bpm and a shock zone at 250 bpm, in the judgment of the implanting physician and/or according to (inter) national guidelines

Where it is running

• Huntsville Hospital - The Heart Center, PC — Huntsville, Alabama, United States
• Mercy Gilbert Medical Center — Gilbert, Arizona, United States
• Mayo Clinic Phoenix — Phoenix, Arizona, United States
• Glendale Adventist Medical Center — Glendale, California, United States
• Sharp Grossmont Hospital — La Mesa, California, United States
• University of Southern California Hospital — Los Angeles, California, United States
• Alta Bates Medical Center — Oakland, California, United States
• St. Joseph Hospital — Orange, California, United States
• Good Samaritan Hospital - San Jose — San Jose, California, United States
• Harbor UCLA Medical Center — Torrance, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Cardiology Physicians PA — Newark, Delaware, United States
• Baptist Medical Center — Jacksonville, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• University Hospital — Augusta, Georgia, United States
• CorVita Science Foundation — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Northern Indiana Research Alliance - Lutheran Hospital — Fort Wayne, Indiana, United States
• Methodist Hospital of Indianapolis — Indianapolis, Indiana, United States
• St. Vincent's Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Alabama Cardiovascular Group — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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