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NCT02433379 · ClinicalTrials.gov registry record · NA
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
A NA study of Ventricular Tachycardia and Ventricular Fibrillation, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 1,173
- Enrollment target
- 20
- Study locations
NCT02433379: Completed NA study of Ventricular Tachycardia and Ventricular Fibrillation, sponsored by Boston Scientific Corporation.
NCT02433379 is a NA study of Ventricular Tachycardia and Ventricular Fibrillation that has completed, run by Boston Scientific Corporation. The registered enrollment target is 1,173 participants, above the 247-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (375% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02433379, a NA study of Ventricular Tachycardia and Ventricular Fibrillation, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,173 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Primary endpoint: Inappropriate shock free rate from 0 to 540 Days (18-Months) compared to a performance goal of 91.6%.
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 |
What the finished NCT02433379 record still lists
NCT02433379 is an interventional study that assigns participants to a tested intervention. Its 1,173 participants enrollment target places it among the larger protocols in the corpus, above the 247-participant average among 28 other Ventricular Tachycardia trials with a reported enrollment target (375% higher).
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.
NCT02433379 names 20 study sites across 8 states, led by California, Florida, Alabama.
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.
What interventions are being tested in trial NCT02433379?
The interventions under investigation include: EMBLEM S-ICD System (DEVICE).
Who is sponsoring clinical trial NCT02433379?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02433379's enrollment target sits among peer trials
1,173 3rd of 28 higher than 26 of 28 other Ventricular Tachycardia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ventricular Tachycardia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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