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S-ICD® System Post Approval Study

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01736618
Collaborator
(none)
1,766
Enrollment
87
Locations
103.1
Actual Duration (Months)
20.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
1766 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study
Actual Study Start Date :
Mar 12, 2013
Actual Primary Completion Date :
Oct 15, 2021
Actual Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm Intervention/Treatment
S-ICD System Implant Attempt

Device: S-ICD System

Outcome Measures

Primary Outcome Measures

  1. Type I Complication Free Rate [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.

  2. Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF [60 months (1800 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

  1. Electrode-Related Complication Free Rate. [60 months (1800 days)]

    A complication is an adverse event that results in permanent loss of device function, invasive intervention or death.

  2. First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF [60 months (1800 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Heart Center Research, LLC Huntsville Alabama United States 35801
2 Cardiovascular Associates of Mesa Mesa Arizona United States 85206
3 Phoenix Cardiovascular Group Phoenix Arizona United States 85006
4 Arizona Arrhythmia Consultants, PLC Scottsdale Arizona United States 85251
5 PIMA Heart Physicians, PC Tucson Arizona United States 85712
6 St. Vincent Heart Clinic Arkansas Little Rock Arkansas United States 72205
7 Providence St. Joseph Medical Center Burbank California United States 91505
8 Sequoia Hospital East Palo Alto California United States 94303
9 Sharp Grossmont Hospital El Cajon California United States 91942
10 California Heart Associates Fountain Valley California United States 92708
11 University of California San Diago La Jolla California United States 92037
12 University of Southern California Los Angeles California United States 90033
13 Huntington Memorial Hospital/Foothill Cardiology Pasadena California United States 91105
14 Sharp Memorial Hospital San Diego California United States 92123
15 St. John's Health Center Santa Monica California United States 90404
16 Memorial Medical Center (UCH-MHS) Colorado Springs Colorado United States 80909
17 Washington Hospital Center Washington District of Columbia United States 20010
18 Cardiac Arrhythmia Services, Inc Fort Lauderdale Florida United States 33432
19 St. Vincent's Ambulatory Care (Jacksonville, FL) Jacksonville Florida United States 32204
20 James A Haley Veterans Affairs Hospital Tampa Florida United States 33612
21 University Community Hospital (Florida Hospital)/Advent Health Tampa Tampa Florida United States 34655
22 Emory University Atlanta Georgia United States 30308
23 University Hospital (Augusta, GA) Augusta Georgia United States 30901
24 Augusta University Augusta Georgia United States 30912
25 Gwinnett Medical Center Lawrenceville Georgia United States 30046
26 St. Joseph Hospital Savannah Georgia United States 31419
27 CorVita Science Foundation Chicago Illinois United States 60605
28 Northwestern University Chicago Illinois United States 60611
29 University of Chicago Chicago Illinois United States 60637
30 Advocate Health and Hospitals Corporation/Midwest Heart Foundation Lombard Illinois United States 60181
31 Parkview Research Center Fort Wayne Indiana United States 46845
32 Indiana University -Ball Muncie Indiana United States 47303
33 St. Luke's Unity Point Cedar Rapids Iowa United States 52043
34 Norton Audobon Hospital Louisville Kentucky United States 40205
35 Union Memorial Hospital Baltimore Maryland United States 21237
36 John's Hopkins University Baltimore Maryland United States 28050
37 Brigham and Women's Hosptial Boston Massachusetts United States 02115
38 University of Michigan Ann Arbor Michigan United States 48075
39 Henry Ford Hospital Detroit Michigan United States 48202
40 Mercy Hospital Coon Rapids Minnesota United States 55433
41 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407
42 Mid-America Heart Institute - St. Luke's Hospital Kansas City Missouri United States 64111
43 Barnes Jewish Hospital Saint Louis Missouri United States 63110
44 Cox Health Center for Research and Innovation Springfield Missouri United States 65807
45 Bergen Cardiology Omaha Nebraska United States 68124
46 Catholic Medical Center Manchester New Hampshire United States 03102
47 Cooper University Hospital Camden New Jersey United States 08103
48 Our Lady of Lourdes Medical Center Haddon Heights New Jersey United States 07035
49 Jersery Shore Medical Center Neptune New Jersey United States 07753
50 Valley Hospital Ridgewood New Jersey United States 07450
51 Albany Medical Center Albany New York United States 12208
52 Maimonides Hospital Brooklyn New York United States 11219
53 Beth Israel Medical Center New York New York United States 10003
54 Mount Sinai New York New York United States 10029
55 Stonybrook University Medical Center Stony Brook New York United States 11794
56 Novant Health Heart and Vascular Charlotte North Carolina United States 28204
57 Duke University Durham North Carolina United States 27710
58 Forsyth Medical Center Winston-Salem North Carolina United States 27103
59 Summa Health Akron Ohio United States 44034
60 Good Samaritan Hospital Cincinnati Ohio United States 45220
61 University Hospital Cleveland Cleveland Ohio United States 44106
62 The Cleveland Clinic Cleveland Ohio United States 44195
63 The Ohio State University Columbus Ohio United States 43210
64 Ohio Health Research Columbus Ohio United States 43214
65 The Toledo Hospital Toledo Ohio United States 43615
66 Lake West Hospital Willoughby Ohio United States 44094
67 Oregon Health Sciences University Portland Oregon United States 97239
68 Drexel University College of Medicine Philadelphia Pennsylvania United States 19102
69 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19140
70 Temple University Philadelphia Pennsylvania United States 19140
71 Medical University of South Carolina Charleston South Carolina United States 29425
72 South Carolina Heart Center Columbia South Carolina United States 29204
73 Vanderbilt University Medical Center Nashville Tennessee United States 37232
74 HeartPlace Mid-Cities EP Bedford Texas United States 76201
75 North Texas Heart Center Dallas Texas United States 75231
76 Univeristy of Texas Health Science Center The Woodlands Texas United States 77384
77 University of Utah Hospital and Clinic Salt Lake City Utah United States 84132
78 University of Virginia Medical Center Charlottesville Virginia United States 22908
79 Inova Fairfax Falls Church Virginia United States 22042
80 Sentara Cardiovascular Research Institute Norfolk Virginia United States 23507
81 Hunter Holmes VA Medical Center Richmond Virginia United States 23249
82 Virginia Cardiovascular Specialists Richmond Virginia United States 23298
83 Virginia Commonwealth Univeristy Richmond Virginia United States 23298
84 University of Washington Medical Center Seattle Washington United States 98195
85 Kootenai Heart Clinics Spokane Washington United States 99204
86 The Vancouver Clinic Vancouver Washington United States 98664
87 St. Mary's Hospital Huntington West Virginia United States 25702

Sponsors and Collaborators

  • Boston Scientific Corporation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01736618
Other Study ID Numbers:
  • BSC CRM CDM00055718
  • BSC CRM CDM00055718
First Posted:
Nov 29, 2012
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Boston Scientific Corporation
subcutaneous implantable defibrillator, post approval study, sudden cardiac arrest, Cameron Health defibrillator
Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac

Study Results

No Results Posted as of May 17, 2022