S-ICD® System Post Approval Study
- Conditions
- Primary Prevention of Sudden Cardiac ArrestSecondary Prevention of Sudden Cardiac Arrest
- Interventions
- Device: S-ICD System
- Registration Number
- NCT01736618
- Lead Sponsor
- Boston Scientific Corporation
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1766
- 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
- Remaining life expectancy of less than 360 days
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description S-ICD System Implant Attempt S-ICD System All participants undergo an S-ICD System Implant attempt.
- Primary Outcome Measures
Name Time Method Number of Participants Free From Type I Complication 60 months (1800 days) 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.
Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF 60 months (1825 days) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Free From Electrode-related Complications 60 months (1800 days) 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.
First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF 60 months (1825 days) 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.
Trial Locations
- Locations (87)
University of Chicago
🇺🇸Chicago, Illinois, United States
John's Hopkins University
🇺🇸Baltimore, Maryland, United States
The Ohio State University
🇺🇸Columbus, Ohio, 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
University Hospital Cleveland
🇺🇸Cleveland, Ohio, United States
The Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Duke University
🇺🇸Durham, North Carolina, United States
Arizona Arrhythmia Consultants, PLC
🇺🇸Scottsdale, Arizona, United States
Memorial Medical Center (UCH-MHS)
🇺🇸Colorado Springs, Colorado, United States
Phoenix Cardiovascular Group
🇺🇸Phoenix, Arizona, United States
James A Haley Veterans Affairs Hospital
🇺🇸Tampa, Florida, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
University Community Hospital (Florida Hospital)/Advent Health Tampa
🇺🇸Tampa, Florida, United States
University of Utah Hospital and Clinic
🇺🇸Salt Lake City, Utah, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Cardiovascular Associates of Mesa
🇺🇸Mesa, Arizona, United States
PIMA Heart Physicians, PC
🇺🇸Tucson, Arizona, United States
St. Vincent Heart Clinic Arkansas
🇺🇸Little Rock, Arkansas, United States
Providence St. Joseph Medical Center
🇺🇸Burbank, California, United States
Sequoia Hospital
🇺🇸East Palo Alto, California, United States
University of California San Diago
🇺🇸La Jolla, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Huntington Memorial Hospital/Foothill Cardiology
🇺🇸Pasadena, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Cardiac Arrhythmia Services, Inc
🇺🇸Fort Lauderdale, Florida, United States
St. Vincent's Ambulatory Care (Jacksonville, FL)
🇺🇸Jacksonville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University Hospital (Augusta, GA)
🇺🇸Augusta, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
St. Joseph Hospital
🇺🇸Savannah, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
St. Luke's Unity Point
🇺🇸Cedar Rapids, Iowa, United States
Indiana University -Ball
🇺🇸Muncie, Indiana, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Norton Audobon Hospital
🇺🇸Louisville, Kentucky, United States
Union Memorial Hospital
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hosptial
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Mid-America Heart Institute - St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Cox Health Center for Research and Innovation
🇺🇸Springfield, Missouri, United States
Bergen Cardiology
🇺🇸Omaha, Nebraska, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Our Lady of Lourdes Medical Center
🇺🇸Haddon Heights, New Jersey, United States
South Carolina Heart Center
🇺🇸Columbia, South Carolina, United States
Jersery Shore Medical Center
🇺🇸Neptune, New Jersey, United States
Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Maimonides Hospital
🇺🇸Brooklyn, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
Stonybrook University Medical Center
🇺🇸Stony Brook, New York, United States
Novant Health Heart and Vascular
🇺🇸Charlotte, North Carolina, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Lake West Hospital
🇺🇸Willoughby, Ohio, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Sharp Grossmont Hospital
🇺🇸El Cajon, California, United States
California Heart Associates
🇺🇸Fountain Valley, California, United States
CorVita Science Foundation
🇺🇸Chicago, Illinois, United States
St. John's Health Center
🇺🇸Santa Monica, California, United States
Advocate Health and Hospitals Corporation/Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Summa Health
🇺🇸Akron, Ohio, United States
Ohio Health Research
🇺🇸Columbus, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
HeartPlace Mid-Cities EP
🇺🇸Bedford, Texas, United States
North Texas Heart Center
🇺🇸Dallas, Texas, United States
Univeristy of Texas Health Science Center
🇺🇸The Woodlands, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax
🇺🇸Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, 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
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Kootenai Heart Clinics
🇺🇸Spokane, Washington, United States
The Vancouver Clinic
🇺🇸Vancouver, Washington, United States
St. Mary's Hospital
🇺🇸Huntington, West Virginia, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States