Tachycardia, VentricularNCT01064076
S-ICD® System IDE Clinical Study
A study testing S-ICD System in people with Tachycardia, Ventricular, run by Boston Scientific Corporation at 33 sites in 4 countries.
Trial summary
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, Ventricular
- What is being tested?
- S-ICD System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 33 sitesin 4 countries
- Study dates
- Jan 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
United States28 sites
Emory University School of Medicine
Atlanta, Georgia, 30308
Cooper University Hospital
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29464
Mid Carolina Cardiology Research
Charlotte, North Carolina, 28204
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Parkview Research Center
Fort Wayne, Indiana, 46805
University of Southern California
Los Angeles, California, 90033
Mount Sinai School of Medicine
New York, New York, 10029
Sentara Heart Hospital
Norfolk, Virginia, 23507
Midwest Heart Foundation
Oakbrook Terrace, Illinois, 60181
Foothill Cardiology
Pasadena, California, 91105
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
CMCA / Sequoia Hospital
Redwood City, California, 94062
Sharp Grossmont Hospital
San Diego, California, 92123
Sharp Memorial Hospital
San Diego, California, 92123
Pacific Heart Institute
Santa Monica, California, 90404
Arizona Arrhythmia Consultants
Scottsdale, Arizona, 85251
University of Washington Medical Center
Seattle, Washington, 98195
Heart Clinics Northwest
Spokane, Washington, 99204
South Bay Electrophysiology
Torrance, California, 90503
The Vancouver Clinic
Vancouver, Washington, 98684
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Erasmus Medical Center
Rotterdam, 3015 GD
New Zealand2 sites
Auckland City Hospital
Auckland, 1001
Christchurch Hospital
Christchurch, 8140
United Kingdom1 site
Papworth Hospital NHS Trust
Papworth Everard, Cambridge, CB3 8RE
About this study
Official title: S-ICD® System Clinical Investigation
This clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (S-ICD) System.
Read the 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.
- Conditions
- Tachycardia, Ventricular
- Being tested
- S-ICD System
- Keywords
- ICD, defibrillator
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ICD SystemDevice
Also called SQ-RX Pulse Generator, Q-TRAK Subcutaneous Electrode, Q-GUIDE Electrode Insertion Tools, Q-TECH Programmer
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).
| Study group | Role | What they receive |
|---|---|---|
| S-ICD System | Experimental | This is a single arm study Receives: Device: S-ICD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
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.
Measured: Implant/Pre-Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tachycardia, VentricularStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Husby, M.S., MPH, Study director, Cameron Health, Inc. a Subsidiary of Boston Scientific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064076
- Sponsor's protocol ID
- DN-03909
- Status last verified
- Jul 2015
- First submitted
- 4 Feb 2010
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30917689Burke 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.
PubMed 25908064Weiss 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.
PubMed 23979626
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-ICD® System Clinical Investigation
- ClinicalTrials.gov ID
- NCT01064076
- Acronym / sponsor ID
- DN-03909
- Conditions
- Tachycardia, Ventricular
- Keywords
- ICD, defibrillator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Posted 27 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-ICD System | Experimental | Device: S-ICD SystemThis is a single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For patients without an existing transvenous device
- For patients with an existing transvenous device
- Age is ≥ 18 years
- An appropriate pre-operative ECG per template provided
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-ICD SystemAlso: SQ-RX Pulse Generator, Q-TRAK Subcutaneous Electrode, Q-GUIDE Electrode Insertion Tools, Q-TECH ProgrammerThe 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). | Device | S-ICD System |
Primary outcome
Percentage of Participants Free of Type I Complications at 180 Days.
Time frame: 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
Time frame: Implant/Pre-Discharge
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30917689Amin 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.
- Derived from this study: PubMed 25908064Burke 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.
- Derived from this study: PubMed 23979626Weiss 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.
- Boston Scientific WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Husby, M.S., MPH study director
Cameron Health, Inc. a Subsidiary of Boston Scientific
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-ICD System in people with Tachycardia, Ventricular, run by Boston Scientific Corporation at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Netherlands, New Zealand, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Free of Type I Complications at 180 Days. (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01064076, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.