S-ICD® System Post Approval Study
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study
1 other identifier
observational
1,766
1 country
87
Brief Summary
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
Longer than P75 for all trials
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedStudy Start
First participant enrolled
March 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2021
CompletedResults Posted
Study results publicly available
March 18, 2024
CompletedMarch 18, 2024
June 1, 2023
8.6 years
November 27, 2012
July 13, 2022
June 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Free From Type I Complication
Type I complications are adverse events caused by a component of the S-ICD System (i.e. pulse generator, electrode, EIT or programmer) that results in permanent loss of device function, invasive intervention or death.
60 months (1800 days)
Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF
Overall shock effectiveness refers to conversion of an episode following on any of the 5 shocks (maximum) that may be delivered during a single episode. Discrete episodes of VT/VF are those that are temporally independent (\<3 within a 24 hour period), unlike storm episodes, which occur in clusters (≥3 episodes within a 24 hour period). Episodes that spontaneously terminate will be excluded from this endpoint since the effectiveness of the shock cannot be evaluated in such circumstances.
60 months (1825 days)
Secondary Outcomes (2)
Number of Participants Free From Electrode-related Complications
60 months (1800 days)
First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF
60 months (1825 days)
Study Arms (1)
S-ICD System Implant Attempt
All participants undergo an S-ICD System Implant attempt.
Interventions
Eligibility Criteria
The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing.
You may qualify if:
- 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)
- AND
- Willing and able to provide written informed consent or have informed consent provided by a legal representative
You may not qualify if:
- Remaining life expectancy of less than 360 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, 85206, United States
Phoenix Cardiovascular Group
Phoenix, Arizona, 85006, United States
Arizona Arrhythmia Consultants, PLC
Scottsdale, Arizona, 85251, United States
PIMA Heart Physicians, PC
Tucson, Arizona, 85712, United States
St. Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205, United States
Providence St. Joseph Medical Center
Burbank, California, 91505, United States
Sequoia Hospital
East Palo Alto, California, 94303, United States
Sharp Grossmont Hospital
El Cajon, California, 91942, United States
California Heart Associates
Fountain Valley, California, 92708, United States
University of California San Diago
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90033, United States
Huntington Memorial Hospital/Foothill Cardiology
Pasadena, California, 91105, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
St. John's Health Center
Santa Monica, California, 90404, United States
Memorial Medical Center (UCH-MHS)
Colorado Springs, Colorado, 80909, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Cardiac Arrhythmia Services, Inc
Fort Lauderdale, Florida, 33432, United States
St. Vincent's Ambulatory Care (Jacksonville, FL)
Jacksonville, Florida, 32204, United States
James A Haley Veterans Affairs Hospital
Tampa, Florida, 33612, United States
University Community Hospital (Florida Hospital)/Advent Health Tampa
Tampa, Florida, 34655, United States
Emory University
Atlanta, Georgia, 30308, United States
University Hospital (Augusta, GA)
Augusta, Georgia, 30901, United States
Augusta University
Augusta, Georgia, 30912, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30046, United States
St. Joseph Hospital
Savannah, Georgia, 31419, United States
CorVita Science Foundation
Chicago, Illinois, 60605, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Advocate Health and Hospitals Corporation/Midwest Heart Foundation
Lombard, Illinois, 60181, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Indiana University -Ball
Muncie, Indiana, 47303, United States
St. Luke's Unity Point
Cedar Rapids, Iowa, 52043, United States
Norton Audobon Hospital
Louisville, Kentucky, 40205, United States
Union Memorial Hospital
Baltimore, Maryland, 21237, United States
John's Hopkins University
Baltimore, Maryland, 28050, United States
Brigham and Women's Hosptial
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48075, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mid-America Heart Institute - St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Cox Health Center for Research and Innovation
Springfield, Missouri, 65807, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Bergen Cardiology
Omaha, Nebraska, 68124, United States
Catholic Medical Center
Manchester, New Hampshire, 03102, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, 07035, United States
Jersery Shore Medical Center
Neptune City, New Jersey, 07753, United States
Valley Hospital
Ridgewood, New Jersey, 07450, United States
Albany Medical Center
Albany, New York, 12208, United States
Maimonides Hospital
Brooklyn, New York, 11219, United States
Beth Israel Medical Center
New York, New York, 10003, United States
Mount Sinai
New York, New York, 10029, United States
Stonybrook University Medical Center
Stony Brook, New York, 11794, United States
Novant Health Heart and Vascular
Charlotte, North Carolina, 28204, United States
Duke University
Durham, North Carolina, 27710, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Summa Health
Akron, Ohio, 44034, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
University Hospital Cleveland
Cleveland, Ohio, 44106, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Ohio Health Research
Columbus, Ohio, 43214, United States
The Toledo Hospital
Toledo, Ohio, 43615, United States
Lake West Hospital
Willoughby, Ohio, 44094, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19140, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
South Carolina Heart Center
Columbia, South Carolina, 29204, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
HeartPlace Mid-Cities EP
Bedford, Texas, 76201, United States
North Texas Heart Center
Dallas, Texas, 75231, United States
Univeristy of Texas Health Science Center
The Woodlands, Texas, 77384, United States
University of Utah Hospital and Clinic
Salt Lake City, Utah, 84132, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax
Falls Church, Virginia, 22042, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Hunter Holmes VA Medical Center
Richmond, Virginia, 23249, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, 23298, United States
Virginia Commonwealth Univeristy
Richmond, Virginia, 23298, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Kootenai Heart Clinics
Spokane, Washington, 99204, United States
The Vancouver Clinic
Vancouver, Washington, 98664, United States
St. Mary's Hospital
Huntington, West Virginia, 25702, United States
Related Publications (6)
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.
PMID: 37676200DERIVEDGold 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.
PMID: 37495274DERIVEDGold 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.
PMID: 35944889DERIVEDBurke 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.
PMID: 33213814DERIVEDEl-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.
PMID: 32376304DERIVEDGold 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.
PMID: 28502872DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Manager or Director of Clinical Trials (Cardiology Rhythm Management)
- Organization
- Boston Scientific - Rhythm Management
Study Officials
- STUDY DIRECTOR
Maria Macuare-Gorden, MD
Boston Scientific Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
November 29, 2012
Study Start
March 12, 2013
Primary Completion
October 15, 2021
Study Completion
October 15, 2021
Last Updated
March 18, 2024
Results First Posted
March 18, 2024
Record last verified: 2023-06