Study Results
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View full resultsBasic Information
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COMPLETED
1766 participants
OBSERVATIONAL
2013-03-12
2021-10-15
Brief Summary
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Detailed Description
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* The primary safety endpoint of the study is the Type I (caused by the S-ICD System) Complication Free Rate at 60 months compared to a performance goal of 85%.
* The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of ventricular tachycardia /ventricular fibrillation (VT/VF) through 60 months compared to a performance goal of 94%.
* The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months compared to a performance goal of 92.5%.
* The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a performance goal of 84.0%.
Additional objectives include characterization of long term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented populations.
Subjects must meet the following criteria to be eligible for inclusion in the study:
1. Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013)
2. Willing and able to provide written informed consent or have informed consent provided by a legal representative
Subjects who meet the following criteria must be excluded from the study:
1\. Remaining life expectancy of less than 360 days
Enrolled subjects will be followed at the implant procedure, pre-discharge and annual (±60 days) follow-up visits. Subjects are followed according to the standard of care at their participating investigational center.
The primary and secondary safety and effectiveness endpoints will include a compilation of S-ICD IDE study and S-ICD PAS study subject data
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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S-ICD System Implant Attempt
All participants undergo an S-ICD System Implant attempt.
S-ICD System
Interventions
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S-ICD System
Eligibility Criteria
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Inclusion Criteria
AND
* Willing and able to provide written informed consent or have informed consent provided by a legal representative
Exclusion Criteria
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Macuare-Gorden, MD
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Heart Center Research, LLC
Huntsville, Alabama, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, United States
Phoenix Cardiovascular Group
Phoenix, Arizona, United States
Arizona Arrhythmia Consultants, PLC
Scottsdale, Arizona, United States
PIMA Heart Physicians, PC
Tucson, Arizona, United States
St. Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States
Providence St. Joseph Medical Center
Burbank, California, United States
Sequoia Hospital
East Palo Alto, California, United States
Sharp Grossmont Hospital
El Cajon, California, United States
California Heart Associates
Fountain Valley, California, United States
University of California San Diago
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
Huntington Memorial Hospital/Foothill Cardiology
Pasadena, California, United States
Sharp Memorial Hospital
San Diego, California, United States
St. John's Health Center
Santa Monica, California, United States
Memorial Medical Center (UCH-MHS)
Colorado Springs, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Cardiac Arrhythmia Services, Inc
Fort Lauderdale, Florida, United States
St. Vincent's Ambulatory Care (Jacksonville, FL)
Jacksonville, Florida, United States
James A Haley Veterans Affairs Hospital
Tampa, Florida, United States
University Community Hospital (Florida Hospital)/Advent Health Tampa
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
University Hospital (Augusta, GA)
Augusta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
St. Joseph Hospital
Savannah, Georgia, United States
CorVita Science Foundation
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Advocate Health and Hospitals Corporation/Midwest Heart Foundation
Lombard, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Indiana University -Ball
Muncie, Indiana, United States
St. Luke's Unity Point
Cedar Rapids, Iowa, United States
Norton Audobon Hospital
Louisville, Kentucky, United States
Union Memorial Hospital
Baltimore, Maryland, United States
John's Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hosptial
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mid-America Heart Institute - St. Luke's Hospital
Kansas City, Missouri, United States
Cox Health Center for Research and Innovation
Springfield, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Bergen Cardiology
Omaha, Nebraska, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, United States
Jersery Shore Medical Center
Neptune City, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Albany Medical Center
Albany, New York, United States
Maimonides Hospital
Brooklyn, New York, United States
Beth Israel Medical Center
New York, New York, United States
Mount Sinai
New York, New York, United States
Stonybrook University Medical Center
Stony Brook, New York, United States
Novant Health Heart and Vascular
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Summa Health
Akron, Ohio, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
University Hospital Cleveland
Cleveland, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Ohio Health Research
Columbus, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Lake West Hospital
Willoughby, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
South Carolina Heart Center
Columbia, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
HeartPlace Mid-Cities EP
Bedford, Texas, United States
North Texas Heart Center
Dallas, Texas, United States
Univeristy of Texas Health Science Center
The Woodlands, Texas, United States
University of Utah Hospital and Clinic
Salt Lake City, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax
Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Hunter Holmes VA Medical Center
Richmond, Virginia, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
Virginia Commonwealth Univeristy
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Kootenai Heart Clinics
Spokane, Washington, United States
The Vancouver Clinic
Vancouver, Washington, United States
St. Mary's Hospital
Huntington, West Virginia, United States
Countries
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References
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Weiss R, Knight BP, El-Chami M, Aasbo J, Hanon S, Sadhu A, Sidhu M, Brisben AJ, Carter N, Burke MC, Gold M. Impact of Age on Subcutaneous Implantable Cardioverter-Defibrillator in a Large Patient Cohort: Mid-Term Follow-Up. JACC Clin Electrophysiol. 2023 Oct;9(10):2132-2145. doi: 10.1016/j.jacep.2023.06.013. Epub 2023 Sep 6.
Gold MR, El-Chami MF, Burke MC, Upadhyay GA, Niebauer MJ, Prutkin JM, Herre JM, Kutalek S, Dinerman JL, Knight BP, Leigh J, Lucas L, Carter N, Brisben AJ, Aasbo JD, Weiss R; S-ICD System Post Approval Study Investigators. Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System. J Am Coll Cardiol. 2023 Aug 1;82(5):383-397. doi: 10.1016/j.jacc.2023.05.034.
Gold MR, Aasbo JD, Weiss R, Burke MC, Gleva MJ, Knight BP, Miller MA, Schuger CD, Carter N, Leigh J, Brisben AJ, El-Chami MF. Infection in patients with subcutaneous implantable cardioverter-defibrillator: Results of the S-ICD Post Approval Study. Heart Rhythm. 2022 Dec;19(12):1993-2001. doi: 10.1016/j.hrthm.2022.07.031. Epub 2022 Aug 6.
Burke MC, Aasbo JD, El-Chami MF, Weiss R, Dinerman J, Hanon S, Kalahasty G, Bass E, Gold MR. 1-Year Prospective Evaluation of Clinical Outcomes and Shocks: The Subcutaneous ICD Post Approval Study. JACC Clin Electrophysiol. 2020 Nov;6(12):1537-1550. doi: 10.1016/j.jacep.2020.05.036. Epub 2020 Aug 26.
El-Chami MF, Burke MC, Herre JM, Shah MH, Sadhu A, Niebauer MJ, Kutalek SP, Carter N, Gold MR. Outcomes of subcutaneous implantable cardioverter-defibrillator in dialysis patients: Results from the S-ICD post-approval study. Heart Rhythm. 2020 Sep;17(9):1566-1574. doi: 10.1016/j.hrthm.2020.04.036. Epub 2020 May 4.
Gold MR, Aasbo JD, El-Chami MF, Niebauer M, Herre J, Prutkin JM, Knight BP, Kutalek S, Hsu K, Weiss R, Bass E, Husby M, Stivland TM, Burke MC. Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results. Heart Rhythm. 2017 Oct;14(10):1456-1463. doi: 10.1016/j.hrthm.2017.05.016. Epub 2017 May 11.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BSC CRM CDM00055718
Identifier Type: REGISTRY
Identifier Source: secondary_id
BSC CRM CDM00055718
Identifier Type: -
Identifier Source: org_study_id
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