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S-ICD® System IDE Clinical Study

Primary Purpose

Tachycardia, Ventricular

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
S-ICD System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia, Ventricular focused on measuring ICD, defibrillator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • For patients without an existing transvenous device

    • Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment

  • For patients with an existing transvenous device

    • Patient requires replacement or revision of an existing implanted transvenous ICD system

  • Age is ≥ 18 years
  • An appropriate pre-operative ECG per template provided

Exclusion Criteria:

  • Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study.
  • Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study.
  • Participation in any other investigational study without prior written consent from the study sponsor.
  • Patients with a serious medical condition and life expectancy of less than one year.
  • Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing, unless the patient is not a candidate for a transvenous ICD system.
  • Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant.
  • Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing.
  • Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.

Sites / Locations

  • Arizona Arrhythmia Consultants
  • University of Southern California
  • Foothill Cardiology
  • CMCA / Sequoia Hospital
  • Sharp Grossmont Hospital
  • Sharp Memorial Hospital
  • Pacific Heart Institute
  • South Bay Electrophysiology
  • Washington Hospital Center
  • Emory University School of Medicine
  • Northwestern University
  • University of Chicago
  • Midwest Heart Foundation
  • Parkview Research Center
  • Cooper University Hospital
  • Mount Sinai School of Medicine
  • Mid Carolina Cardiology Research
  • Forsyth Medical Center
  • Cleveland Clinic Foundation
  • The Ohio State University
  • Drexel University College of Medicine
  • Hospital of the University of Pennsylvania
  • Medical University of South Carolina
  • Inova Fairfax Hospital
  • Sentara Heart Hospital
  • University of Washington Medical Center
  • Heart Clinics Northwest
  • The Vancouver Clinic
  • St. Antonius Ziekenhuis
  • Erasmus Medical Center
  • Auckland City Hospital
  • Christchurch Hospital
  • Papworth Hospital NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-ICD System

Arm Description

This is a single arm study

Outcomes

Primary Outcome Measures

Percentage of Participants Free of Type I Complications at 180 Days.
Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.
Percentage of Participants Who Pass Induced VF Conversion Test
Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2010
Last Updated
February 7, 2017
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01064076
Brief Title
S-ICD® System IDE Clinical Study
Official Title
S-ICD® System Clinical Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
Detailed Description
This clinical study is a prospective, non-randomized, multicenter clinical study without a control group conducted in the United States, Europe, and New Zealand. Patients meeting eligibility criteria for implanting an S-ICD System will be enrolled in this clinical study, implanted with an S-ICD System, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure. Eligible patients enrolled in this clinical study may also participate in the chronic conversion sub-study. The safety endpoint will be evaluated through the use of a 180-day S-ICD System complication-free rate. The effectiveness endpoint will be evaluated using an induced ventricular fibrillation (VF) conversion efficacy rate. Spontaneous episodes and chronic conversion testing data will be evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the S-ICD System.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia, Ventricular
Keywords
ICD, defibrillator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-ICD System
Arm Type
Experimental
Arm Description
This is a single arm study
Intervention Type
Device
Intervention Name(s)
S-ICD System
Other Intervention Name(s)
SQ-RX Pulse Generator, Q-TRAK Subcutaneous Electrode, Q-GUIDE Electrode Insertion Tools, Q-TECH Programmer
Intervention Description
The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the SQ-RX pulse generator (Model 1010), the Q-TRAK subcutaneous electrode (Model 3010), the Q-TECH programmer (Model 2020), and Q-GUIDE electrode insertion tools (Models 4010 and 4020).
Primary Outcome Measure Information:
Title
Percentage of Participants Free of Type I Complications at 180 Days.
Description
Percentage of Participants Free of Type I Complications at 180 days compared to the performance goal of 79%. Type I complications are those caused by the S-ICD System.
Time Frame
180 days
Title
Percentage of Participants Who Pass Induced VF Conversion Test
Description
Percentage of participants who pass induced VF conversion test was compared to a performance goal of 88%. Definition of a success was two consecutive successful 65 joule shocks out of four attempts in the same polarity.
Time Frame
Implant/Pre-Discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For patients without an existing transvenous device • Patient meets Class I, Class IIa or Class IIb indications/recommendations for ICD implantation per the current published guidelines at the time of enrollment For patients with an existing transvenous device • Patient requires replacement or revision of an existing implanted transvenous ICD system Age is ≥ 18 years An appropriate pre-operative ECG per template provided Exclusion Criteria: Any condition which precludes the subject's ability to comply with the study requirements, including completion of the study. Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study. Participation in any other investigational study without prior written consent from the study sponsor. Patients with a serious medical condition and life expectancy of less than one year. Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing, unless the patient is not a candidate for a transvenous ICD system. Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant. Patients with unipolar pacemakers or implanted devices that revert to unipolar pacing. Patients with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Husby, M.S., MPH
Organizational Affiliation
Cameron Health, Inc. a Subsidiary of Boston Scientific
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Arrhythmia Consultants
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Foothill Cardiology
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
CMCA / Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
Sharp Grossmont Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pacific Heart Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
South Bay Electrophysiology
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Midwest Heart Foundation
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mid Carolina Cardiology Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Sentara Heart Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Heart Clinics Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
The Vancouver Clinic
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1001
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8140
Country
New Zealand
Facility Name
Papworth Hospital NHS Trust
City
Papworth Everard
State/Province
Cambridge
ZIP/Postal Code
CB3 8RE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30917689
Citation
Amin AK, Gold MR, Burke MC, Knight BP, Rajjoub MR, Duffy E, Husby M, Stahl WK, Weiss R. Factors Associated With High-Voltage Impedance and Subcutaneous Implantable Defibrillator Ventricular Fibrillation Conversion Success. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006665. doi: 10.1161/CIRCEP.118.006665.
Results Reference
derived
PubMed Identifier
25908064
Citation
Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.
Results Reference
derived
PubMed Identifier
23979626
Citation
Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M, Rashtian M, Kremers M, Crozier I, Lee KL, Smith W, Burke MC. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation. 2013 Aug 27;128(9):944-53. doi: 10.1161/CIRCULATIONAHA.113.003042.
Results Reference
derived
Links:
URL
http://www.bostonscientific.com
Description
Boston Scientific Website

Learn more about this trial

S-ICD® System IDE Clinical Study

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