S-ICD® System Post Approval Study

Primary Prevention of Sudden Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736618
• Other study ID #: BSC CRM CDM00055718
• Secondary ID: BSC CRM CDM00055
• Status: Completed
• Start date: March 12, 2013
• Est. completion date: October 15, 2021

Study information

• Verified date: June 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1766
• Est. completion date: October 15, 2021
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Primary Prevention of Sudden Cardiac Arrest
• Secondary Prevention of Sudden Cardiac Arrest

Intervention

Device:
• S-ICD System

Locations

Country	Name	City	State
United States	Summa Health	Akron	Ohio
United States	Albany Medical Center	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University Hospital (Augusta, GA)	Augusta	Georgia
United States	John's Hopkins University	Baltimore	Maryland
United States	Union Memorial Hospital	Baltimore	Maryland
United States	HeartPlace Mid-Cities EP	Bedford	Texas
United States	Brigham and Women's Hosptial	Boston	Massachusetts
United States	Maimonides Hospital	Brooklyn	New York
United States	Providence St. Joseph Medical Center	Burbank	California
United States	Cooper University Hospital	Camden	New Jersey
United States	St. Luke's Unity Point	Cedar Rapids	Iowa
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Novant Health Heart and Vascular	Charlotte	North Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	CorVita Science Foundation	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	The Cleveland Clinic	Cleveland	Ohio
United States	University Hospital Cleveland	Cleveland	Ohio
United States	Memorial Medical Center (UCH-MHS)	Colorado Springs	Colorado
United States	South Carolina Heart Center	Columbia	South Carolina
United States	Ohio Health Research	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	North Texas Heart Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	Sequoia Hospital	East Palo Alto	California
United States	Sharp Grossmont Hospital	El Cajon	California
United States	Inova Fairfax	Falls Church	Virginia
United States	Cardiac Arrhythmia Services, Inc	Fort Lauderdale	Florida
United States	Parkview Research Center	Fort Wayne	Indiana
United States	California Heart Associates	Fountain Valley	California
United States	Our Lady of Lourdes Medical Center	Haddon Heights	New Jersey
United States	St. Mary's Hospital	Huntington	West Virginia
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	St. Vincent's Ambulatory Care (Jacksonville, FL)	Jacksonville	Florida
United States	Mid-America Heart Institute - St. Luke's Hospital	Kansas City	Missouri
United States	University of California San Diago	La Jolla	California
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	St. Vincent Heart Clinic Arkansas	Little Rock	Arkansas
United States	Advocate Health and Hospitals Corporation/Midwest Heart Foundation	Lombard	Illinois
United States	University of Southern California	Los Angeles	California
United States	Norton Audobon Hospital	Louisville	Kentucky
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Cardiovascular Associates of Mesa	Mesa	Arizona
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Indiana University -Ball	Muncie	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Jersery Shore Medical Center	Neptune	New Jersey
United States	Beth Israel Medical Center	New York	New York
United States	Mount Sinai	New York	New York
United States	Sentara Cardiovascular Research Institute	Norfolk	Virginia
United States	Bergen Cardiology	Omaha	Nebraska
United States	Huntington Memorial Hospital/Foothill Cardiology	Pasadena	California
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	Phoenix Cardiovascular Group	Phoenix	Arizona
United States	Oregon Health Sciences University	Portland	Oregon
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	Valley Hospital	Ridgewood	New Jersey
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	University of Utah Hospital and Clinic	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	St. John's Health Center	Santa Monica	California
United States	St. Joseph Hospital	Savannah	Georgia
United States	Arizona Arrhythmia Consultants, PLC	Scottsdale	Arizona
United States	University of Washington Medical Center	Seattle	Washington
United States	Kootenai Heart Clinics	Spokane	Washington
United States	Cox Health Center for Research and Innovation	Springfield	Missouri
United States	Stonybrook University Medical Center	Stony Brook	New York
United States	James A Haley Veterans Affairs Hospital	Tampa	Florida
United States	University Community Hospital (Florida Hospital)/Advent Health Tampa	Tampa	Florida
United States	Univeristy of Texas Health Science Center	The Woodlands	Texas
United States	The Toledo Hospital	Toledo	Ohio
United States	PIMA Heart Physicians, PC	Tucson	Arizona
United States	The Vancouver Clinic	Vancouver	Washington
United States	Washington Hospital Center	Washington	District of Columbia
United States	Lake West Hospital	Willoughby	Ohio
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)