CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,173 enrolled
Drug / intervention
EMBLEM S-ICD Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02433379
NCT02433379N/ACompleted
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Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction

Boston Scientific Corporation·interventional·Posted May 5, 2015·Updated Mar 24, 2025

In Brief

A clinical study evaluating EMBLEM S-ICD System for Ventricular Fibrillation and 2 related conditions. Completed, enrolled 1,173 participants across 110 sites in 13 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Fibrillation, Ventricular Tachycardia, Low Cardiac Output
CountriesBelgium, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Puerto Rico, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 5, 2015
Enrollment StartJun 9, 2015
Primary CompletionDec 6, 2019
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 11.2 years ago

Interventions

EMBLEM S-ICD Systemdevice

The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp