S-ICD® System Post Approval Study

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study

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.

Study Overview

• Status: Completed
• Conditions: Primary Prevention of Sudden Cardiac Arrest; Secondary Prevention of Sudden Cardiac Arrest
• Intervention / Treatment: Device: S-ICD System

Detailed Description

The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new candidates for the S-ICD System. The target enrollment sample size is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort at 60 months.

• 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

• Study Type: Observational
• Enrollment (Actual): 1766

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Cardiovascular Associates of Mesa
    • Phoenix, Arizona, United States, 85006
      • Phoenix Cardiovascular Group
    • Scottsdale, Arizona, United States, 85251
      • Arizona Arrhythmia Consultants, PLC
    • Tucson, Arizona, United States, 85712
      • Pima Heart Physicians, PC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • St. Vincent Heart Clinic Arkansas
  • California
    • Burbank, California, United States, 91505
      • Providence St. Joseph Medical Center
    • East Palo Alto, California, United States, 94303
      • Sequoia Hospital
    • El Cajon, California, United States, 91942
      • Sharp Grossmont Hospital
    • Fountain Valley, California, United States, 92708
      • California Heart Associates
    • La Jolla, California, United States, 92037
      • University of California San Diago
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Pasadena, California, United States, 91105
      • Huntington Memorial Hospital/Foothill Cardiology
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Santa Monica, California, United States, 90404
      • St. John's Health Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Memorial Medical Center (UCH-MHS)
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33432
      • Cardiac Arrhythmia Services, Inc
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Ambulatory Care (Jacksonville, FL)
    • Tampa, Florida, United States, 33612
      • James A Haley Veterans Affairs Hospital
    • Tampa, Florida, United States, 34655
      • University Community Hospital (Florida Hospital)/Advent Health Tampa
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
    • Augusta, Georgia, United States, 30912
      • Augusta University
    • Augusta, Georgia, United States, 30901
      • University Hospital (Augusta, GA)
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Medical Center
    • Savannah, Georgia, United States, 31419
      • St. Joseph Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60605
      • CorVita Science Foundation
    • Lombard, Illinois, United States, 60181
      • Advocate Health and Hospitals Corporation/Midwest Heart Foundation
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
    • Muncie, Indiana, United States, 47303
      • Indiana University -Ball
  • Iowa
    • Cedar Rapids, Iowa, United States, 52043
      • St. Luke's Unity Point
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Norton Audobon Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Union Memorial Hospital
    • Baltimore, Maryland, United States, 28050
      • John's Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hosptial
  • Michigan
    • Ann Arbor, Michigan, United States, 48075
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid-America Heart Institute - St. Luke's Hospital
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
    • Springfield, Missouri, United States, 65807
      • Cox Health Center for Research and Innovation
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Bergen Cardiology
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Haddon Heights, New Jersey, United States, 07035
      • Our Lady of Lourdes Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersery Shore Medical Center
    • Ridgewood, New Jersey, United States, 07450
      • Valley Hospital
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Brooklyn, New York, United States, 11219
      • Maimonides Hospital
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai
    • Stony Brook, New York, United States, 11794
      • Stonybrook University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Heart and Vascular
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Ohio
    • Akron, Ohio, United States, 44034
      • Summa Health
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospital Cleveland
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research
    • Toledo, Ohio, United States, 43615
      • The Toledo Hospital
    • Willoughby, Ohio, United States, 44094
      • Lake West Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Philadelphia, Pennsylvania, United States, 19140
      • Hospital of the University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Bedford, Texas, United States, 76201
      • HeartPlace Mid-Cities EP
    • Dallas, Texas, United States, 75231
      • North Texas Heart Center
    • The Woodlands, Texas, United States, 77384
      • Univeristy of Texas Health Science Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital and Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular Research Institute
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes VA Medical Center
    • Richmond, Virginia, United States, 23298
      • Virginia Cardiovascular Specialists
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth Univeristy
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
    • Spokane, Washington, United States, 99204
      • Kootenai Heart Clinics
    • Vancouver, Washington, United States, 98664
      • The Vancouver Clinic
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Remaining life expectancy of less than 360 days

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
S-ICD System Implant Attempt; All participants undergo an S-ICD System Implant attempt.	Device: S-ICD System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Free From Electrode-related Complications	The electrode related complications analyzed for this end-point include: complications occurring less than or equal to 30 days post implant that are attributable to structural electrode failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation or breakage or insulation failure; OR occurring greater than 30 days post implant regardless of structural failure for electrode movement, electrode impendence out of range, electrode conductor fracture, deformation/breakage or insulation failure; OR occurring greater than 30 days post implant attributable to structural electrode failure for incomplete/improper header connection, in-subject damage to electrode, electrode revision to optimize therapy, electrode movement, infection, oversensing/undersensing. Additionally, a complication is an adverse event that results in permanent loss of device function, invasive intervention or death.	60 months (1800 days)
First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF	The rate in first shock effectiveness in converting induced (acute) and spontaneous discrete episodes of VT/VF through 60 months (1825 days) is calculated as the number of successful first shock conversions divided by the total evaluable episodes Acute Tests included: S-ICD PAS Study: Acute tests include induced episodes during the initial implant hospitalization after enrollment. Inductions may have been done on different days, but all occurred before the patient was discharged after initial implant; IDE Study : Acute tests included induced episodes occurring during the initial implant procedure as well as subsequent hospitalization until the final system position was obtained.; Acute Test Shock Energy Levels included all energy levels in the PAS Study and only 65 Joule shocks in the IDE Study.; Acute Test Arrhythmias included all VT and VF episodes for the PAS Study and only VF episodes for the IDE Study.	60 months (1825 days)

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Maria Macuare-Gorden, MD, Boston Scientific Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2013
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: November 27, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimated): November 29, 2012

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: subcutaneous implantable defibrillator, post approval study, sudden cardiac arrest, Cameron Health defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: BSC CRM CDM00055718 (Registry Identifier: S-ICD® PAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes