Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
Public ClinicalTrials.gov record NCT02433379. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT02433379
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,173 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2015 (Actual)
- Primary completion
- Dec 6, 2019 (Actual)
- Completion
- Dec 6, 2019 (Actual)
- Last update posted
- Mar 24, 2025
2015 – 2019
United States locations
- U.S. sites
- 69
- U.S. states
- 31
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Cardiovascular Group | Birmingham | Alabama | 35205 | — |
| Huntsville Hospital - The Heart Center, PC | Huntsville | Alabama | 35801 | — |
| Mercy Gilbert Medical Center | Gilbert | Arizona | 85297 | — |
| Mayo Clinic Phoenix | Phoenix | Arizona | 85054 | — |
| Glendale Adventist Medical Center | Glendale | California | 91206 | — |
| Sharp Grossmont Hospital | La Mesa | California | 91942 | — |
| University of Southern California Hospital | Los Angeles | California | 90033-4612 | — |
| Alta Bates Medical Center | Oakland | California | 94609 | — |
| St. Joseph Hospital | Orange | California | 92868 | — |
| Good Samaritan Hospital - San Jose | San Jose | California | 95124 | — |
| Harbor UCLA Medical Center | Torrance | California | 90502 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| Cardiology Physicians PA | Newark | Delaware | 19713 | — |
| Baptist Medical Center | Jacksonville | Florida | 32207 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| University Hospital | Augusta | Georgia | 30901 | — |
| CorVita Science Foundation | Chicago | Illinois | 60605 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Northern Indiana Research Alliance - Lutheran Hospital | Fort Wayne | Indiana | 60611 | — |
| Methodist Hospital of Indianapolis | Indianapolis | Indiana | 46202 | — |
| St. Vincent's Hospital | Indianapolis | Indiana | 46260 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Heartland Cardiology | Wichita | Kansas | 67214 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Advanced Cardiovascular Specialists | Shreveport | Louisiana | 71103 | — |
| Peninsula Cardiology Associates | Salisbury | Maryland | 21804 | — |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| CardioVascular Institute of Michigan P.C. | Roseville | Michigan | 48066 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Centracare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | — |
| HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| Mercy Research | Springfield | Missouri | 65804 | — |
| Cox Health | Springfield | Missouri | 65807 | — |
| The Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| HealthCare Partners Cardiology | Las Vegas | Nevada | 89169 | — |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | — |
| Cooper Hospital - University Medical Center | Camden | New Jersey | 08103 | — |
| Cardiovascular Associates of the Delaware Valley | Sewell | New Jersey | 08080 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Northwell Health | New Hyde Park | New York | 11040 | — |
| Beth Israel Medical Center | New York | New York | 10003 | — |
| Strong Memorial Hospital of the University of Rochester | Rochester | New York | 14642 | — |
| Memorial Mission Hospital | Asheville | North Carolina | 28801 | — |
| University of North Carolina Hospital | Chapel Hill | North Carolina | 27599 | — |
| Durham VA Medical Center | Durham | North Carolina | 27705 | — |
| Rex Hospital | Raleigh | North Carolina | 27607 | — |
| Aultman Hospital | Canton | Ohio | 44710 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| The Toledo Hospital | Toledo | Ohio | 43606 | — |
| Genesis Healthcare System | Zanesville | Ohio | 43701 | — |
| Salem Hospital | Salem | Oregon | 97301 | — |
| Sacred Heart Medical Center at Riverbend | Springfield | Oregon | 97477 | — |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| AnMed Health | Anderson | South Carolina | 29621 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0001 | — |
| South Texas Veterans Health Care System | San Antonio | Texas | 78229 | — |
| Trinity Mother Frances Health System | Tyler | Texas | 75701 | — |
| University of Utah Hospital and Clinics | Salt Lake City | Utah | 84132 | — |
| Centra Stroobants Cardiovascular Center | Lynchburg | Virginia | 24501 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23219 | — |
| Evergreen Hospital Medical Center | Kirkland | Washington | 98034 | — |
| CHI Franciscan Health System | Tacoma | Washington | 98405 | — |
| St. Mary's Madison | Madison | Wisconsin | 53715 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02433379, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2025 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02433379 live on ClinicalTrials.gov.