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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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

Exclusion Criteria:

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Luis Scott, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Luis Scott, M.D.

Closed for enrollment

More information

Publications

The UNTOUCHED study will assess the safety and efficacy of the subcutaneous implantable cardioverter defibrillator (S-ICD) in the most common cohort of patients receiving ICDs. The primary goal is to evaluate the inappropriate shock (IAS)-free rate in primary prevention patients with a reduced ejection fraction (EF) and compare with a historical control of transvenous ICD patients with similar programming. Read More on PubMed
The implantable cardioverter-defibrillator (ICD) is highly effective in reducing mortality among patients at risk for fatal arrhythmias, but inappropriate ICD activations are frequent, with potential adverse effects. Read More on PubMed

Clinical Trials