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Primary Prevention of Sudden Cardiac ArrestNCT01736618

S-ICD® System Post Approval Study

An observational study of Primary Prevention of Sudden Cardiac Arrest and Secondary Prevention of Sudden Cardiac Arrest, run by Boston Scientific Corporation at 87 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
S-ICD System
Type of treatment
Medical device
How many people
1,766 participants
Where
87 sitesUnited States
Study dates
12 Mar 2013to 15 Oct 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Remaining life expectancy of less than 360 days

Trial locations and contacts

87 sites in 1 country.

87 sites in 1 country

United States87 sites

  • Summa Health

    Akron, Ohio, 44034

  • Albany Medical Center

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48075

  • Emory University

    Atlanta, Georgia, 30308

  • University Hospital (Augusta, GA)

    Augusta, Georgia, 30901

  • Augusta University

    Augusta, Georgia, 30912

  • Union Memorial Hospital

    Baltimore, Maryland, 21237

  • John's Hopkins University

    Baltimore, Maryland, 28050

  • HeartPlace Mid-Cities EP

    Bedford, Texas, 76201

  • Brigham and Women's Hosptial

    Boston, Massachusetts, 02115

  • Maimonides Hospital

    Brooklyn, New York, 11219

  • Providence St. Joseph Medical Center

    Burbank, California, 91505

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • St. Luke's Unity Point

    Cedar Rapids, Iowa, 52043

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Novant Health Heart and Vascular

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • CorVita Science Foundation

    Chicago, Illinois, 60605

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • University Hospital Cleveland

    Cleveland, Ohio, 44106

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • Memorial Medical Center (UCH-MHS)

    Colorado Springs, Colorado, 80909

  • South Carolina Heart Center

    Columbia, South Carolina, 29204

  • The Ohio State University

    Columbus, Ohio, 43210

  • Ohio Health Research

    Columbus, Ohio, 43214

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • North Texas Heart Center

    Dallas, Texas, 75231

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • Sequoia Hospital

    East Palo Alto, California, 94303

  • Sharp Grossmont Hospital

    El Cajon, California, 91942

  • Inova Fairfax

    Falls Church, Virginia, 22042

  • Cardiac Arrhythmia Services, Inc

    Fort Lauderdale, Florida, 33432

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • California Heart Associates

    Fountain Valley, California, 92708

  • Our Lady of Lourdes Medical Center

    Haddon Heights, New Jersey, 07035

  • St. Mary's Hospital

    Huntington, West Virginia, 25702

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • St. Vincent's Ambulatory Care (Jacksonville, FL)

    Jacksonville, Florida, 32204

  • Mid-America Heart Institute - St. Luke's Hospital

    Kansas City, Missouri, 64111

  • University of California San Diago

    La Jolla, California, 92037

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30046

  • St. Vincent Heart Clinic Arkansas

    Little Rock, Arkansas, 72205

  • Advocate Health and Hospitals Corporation/Midwest Heart Foundation

    Lombard, Illinois, 60181

  • University of Southern California

    Los Angeles, California, 90033

  • Norton Audobon Hospital

    Louisville, Kentucky, 40205

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85206

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Indiana University -Ball

    Muncie, Indiana, 47303

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Jersery Shore Medical Center

    Neptune City, New Jersey, 07753

  • Beth Israel Medical Center

    New York, New York, 10003

  • Mount Sinai

    New York, New York, 10029

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

  • Bergen Cardiology

    Omaha, Nebraska, 68124

  • Huntington Memorial Hospital/Foothill Cardiology

    Pasadena, California, 91105

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19140

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Phoenix Cardiovascular Group

    Phoenix, Arizona, 85006

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Hunter Holmes VA Medical Center

    Richmond, Virginia, 23249

  • Virginia Cardiovascular Specialists

    Richmond, Virginia, 23298

  • Virginia Commonwealth Univeristy

    Richmond, Virginia, 23298

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • University of Utah Hospital and Clinic

    Salt Lake City, Utah, 84132

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • St. John's Health Center

    Santa Monica, California, 90404

  • St. Joseph Hospital

    Savannah, Georgia, 31419

  • Arizona Arrhythmia Consultants, PLC

    Scottsdale, Arizona, 85251

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Kootenai Heart Clinics

    Spokane, Washington, 99204

  • Cox Health Center for Research and Innovation

    Springfield, Missouri, 65807

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stonybrook University Medical Center

    Stony Brook, New York, 11794

  • James A Haley Veterans Affairs Hospital

    Tampa, Florida, 33612

  • University Community Hospital (Florida Hospital)/Advent Health Tampa

    Tampa, Florida, 34655

  • Univeristy of Texas Health Science Center

    The Woodlands, Texas, 77384

  • The Toledo Hospital

    Toledo, Ohio, 43615

  • PIMA Heart Physicians, PC

    Tucson, Arizona, 85712

  • The Vancouver Clinic

    Vancouver, Washington, 98664

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Lake West Hospital

    Willoughby, Ohio, 44094

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the 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

Being tested
S-ICD System
Keywords
subcutaneous implantable defibrillator, post approval study, sudden cardiac arrest, Cameron Health defibrillator
Medical subject headings
Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S-ICD SystemDevice

Study groups in NCT01736618
Study groupRoleWhat they receive
S-ICD System Implant AttemptAll participants undergo an S-ICD System Implant attempt.
Receives: Device: S-ICD System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 60 months (1800 days)

  2. 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.

    Measured: 60 months (1825 days)

Secondary outcomes (2)

  1. 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.

    Measured: 60 months (1800 days)

  2. 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.

    Measured: 60 months (1825 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study start12 Mar 2013
  3. Primary completion15 Oct 2021
  4. Study completion15 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736618
Sponsor's protocol ID
BSC CRM CDM00055718
Other IDs
BSC CRM CDM00055718
Status last verified
Jun 2023
First submitted
27 Nov 2012
Last updated
18 Mar 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 37676200

  • 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.

    PubMed 37495274

  • 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.

    PubMed 35944889

  • 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.

    PubMed 33213814

  • 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.

    PubMed 32376304

  • 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.

    PubMed 28502872

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Prevention of Sudden Cardiac Arrest and Secondary Prevention of Sudden Cardiac Arrest, run by Boston Scientific Corporation at 87 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Free From Type I Complication (time frame: 60 months (1800 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736618, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.

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