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Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
NCT02433379 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE EMBLEM S-ICD System
Study Locations (20)
California
- Glendale Adventist Medical Center — Glendale
- Sharp Grossmont Hospital — La Mesa
- University of Southern California Hospital — Los Angeles
- Alta Bates Medical Center — Oakland
- St. Joseph Hospital — Orange
- Good Samaritan Hospital - San Jose — San Jose
- Harbor UCLA Medical Center — Torrance
Florida
- Baptist Medical Center — Jacksonville
- Florida Hospital — Orlando
- Tallahassee Memorial Hospital — Tallahassee
Alabama
- Alabama Cardiovascular Group — Birmingham
- Huntsville Hospital - The Heart Center, PC — Huntsville
Arizona
- Mercy Gilbert Medical Center — Gilbert
- Mayo Clinic Phoenix — Phoenix
Georgia
- Emory University Hospital — Atlanta
- University Hospital — Augusta
Illinois
- CorVita Science Foundation — Chicago
- Northwestern Memorial Hospital — Chicago
Connecticut
- Yale University School of Medicine — New Haven
Delaware
- Cardiology Physicians PA — Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,173 participants |
| Start Date | 2015-06-09 |
| Est. Completion | 2019-12-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02433379
The ClinicalTrials.gov registry entry for NCT02433379 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Ventricular Tachycardia appearing as the primary indexed condition, and to 1 intervention — of which EMBLEM S-ICD System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02433379 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02433379 about?
NCT02433379 is a clinical study titled "Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction". 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 programm...
What is the current status of trial NCT02433379?
This trial is currently completed. It is a NA study. The enrollment target is 1,173 participants. The study started on 2015-06-09. Estimated completion is 2019-12-06.
What conditions does trial NCT02433379 study?
This clinical trial studies the following conditions: Ventricular Tachycardia, Ventricular Fibrillation, Low Cardiac Output. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02433379?
The interventions under investigation include: EMBLEM S-ICD System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02433379?
This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02433379 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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