Clinical trial NCT01736618: S-ICD® System Post Approval Study
Official title: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Prevention of Sudden Cardiac Arrest
Secondary Prevention of Sudden Cardiac Arrest
Keywords: subcutaneous implantable defibrillator, post approval study, sudden cardiac arrest, Cameron Health defibrillator
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 1766
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Free From Type I Complication
timeFrame: 60 months (1800 days)
measure: Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF
timeFrame: 60 months (1825 days)
Secondary outcomes:
measure: Number of Participants Free From Electrode-related Complications
timeFrame: 60 months (1800 days)
measure: First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF
timeFrame: 60 months (1825 days)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Group
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants, PLC
state: Arizona
city: Tucson
country: United States
facility: PIMA Heart Physicians, PC
state: Arizona
city: Little Rock
country: United States
facility: St. Vincent Heart Clinic Arkansas
state: Arkansas
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: East Palo Alto
country: United States
facility: Sequoia Hospital
state: California
city: El Cajon
country: United States
facility: Sharp Grossmont Hospital
state: California
city: Fountain Valley
country: United States
facility: California Heart Associates
state: California
city: La Jolla
country: United States
facility: University of California San Diago
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Pasadena
country: United States
facility: Huntington Memorial Hospital/Foothill Cardiology
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Santa Monica
country: United States
facility: St. John's Health Center
state: California
city: Colorado Springs
country: United States
facility: Memorial Medical Center (UCH-MHS)
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Cardiac Arrhythmia Services, Inc
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Ambulatory Care (Jacksonville, FL)
state: Florida
city: Tampa
country: United States
facility: James A Haley Veterans Affairs Hospital
state: Florida
city: Tampa
country: United States
facility: University Community Hospital (Florida Hospital)/Advent Health Tampa
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: University Hospital (Augusta, GA)
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Savannah
country: United States
facility: St. Joseph Hospital
state: Georgia
city: Chicago
country: United States
facility: CorVita Science Foundation
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Lombard
country: United States
facility: Advocate Health and Hospitals Corporation/Midwest Heart Foundation
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Muncie
country: United States
facility: Indiana University -Ball
state: Indiana
city: Cedar Rapids
country: United States
facility: St. Luke's Unity Point
state: Iowa
city: Louisville
country: United States
facility: Norton Audobon Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: John's Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hosptial
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Mid-America Heart Institute - St. Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Health Center for Research and Innovation
state: Missouri
city: Omaha
country: United States
facility: Bergen Cardiology
state: Nebraska
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Haddon Heights
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersery Shore Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Brooklyn
country: United States
facility: Maimonides Hospital
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stonybrook University Medical Center
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Cleveland
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Willoughby
country: United States
facility: Lake West Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Bedford
country: United States
facility: HeartPlace Mid-Cities EP
state: Texas
city: Dallas
country: United States
facility: North Texas Heart Center
state: Texas
city: The Woodlands
country: United States
facility: Univeristy of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinic
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax
state: Virginia
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth Univeristy
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Spokane
country: United States
facility: Kootenai Heart Clinics
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic
state: Washington
city: Huntington
country: United States
facility: St. Mary's Hospital
state: West Virginia
Study officials:
affiliation: Boston Scientific Corporation
name: Maria Macuare-Gorden, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.