Ventricular TachyarrhythmiasChronic IINCT00853645
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
A study testing Subcutaneous Implantable Defibrillator (S-ICD) System in people with Ventricular Tachyarrhythmias, run by Boston Scientific Corporation at 2 sites in New Zealand.
Trial summary
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachyarrhythmias
- What is being tested?
- Subcutaneous Implantable Defibrillator (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
- 6 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Jul 2008to Sep 2008
- 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
- replacement of an existing transvenous implantable cardioverter defibrillator (ICD) system
- American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation
- Age >= 18 years
- Appropriate pre-operative Electrocardiogram (ECG) as measured with a specially developed template
Who cannot join
- Subjects unable or unwilling to provide informed consent
- Any condition which precludes the subject's ability to comply with the study requirements
- 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 another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
- Patients with a serious medical condition and life expectancy of less than one year.
- Patients with documented spontaneous and frequently recurring ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing
- Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
- Patients with chronic renal failure, i.e. with a creatinine level of >2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be <= 3mg/dl
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Auckland City Hospital
Auckland, 1001
Christchurch Hospital
Christchurch, 8140
About this study
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
- Conditions
- Ventricular Tachyarrhythmias
- Being tested
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous Implantable Defibrillator (S-ICD) SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous implantable cardioverter defibrillator (S-ICD) System | Experimental | Single-arm with 6 patients implanted with an S-ICD System Receives: Device: Subcutaneous Implantable Defibrillator (S-ICD) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
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 (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachyarrhythmiasStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen O'Connor, PhD, Hon FRACP, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853645
- Sponsor's protocol ID
- DN-11398
- Acronym
- Chronic II
- Status last verified
- Jul 2021
- First submitted
- 27 Feb 2009
- Last updated
- 6 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, Fynn SP, Murgatroyd FD, Sperzel J, Neuzner J, Spitzer SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel PF, Knops RE, Barr CS, Lupo P, Cappato R, Grace AA. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010 Jul 1;363(1):36-44. doi: 10.1056/NEJMoa0909545. Epub 2010 May 12.
PubMed 20463331
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
- ClinicalTrials.gov ID
- NCT00853645
- Acronym / sponsor ID
- Chronic II / DN-11398
- Conditions
- Ventricular Tachyarrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2008 (actual)
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous implantable cardioverter defibrillator (S-ICD) System | Experimental | Device: Subcutaneous Implantable Defibrillator (S-ICD) SystemSingle-arm with 6 patients implanted with an S-ICD System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- replacement of an existing transvenous implantable cardioverter defibrillator (ICD) system
- American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation
- Age >= 18 years
- Appropriate pre-operative Electrocardiogram (ECG) as measured with a specially developed template
Key exclusion criteria (8 listed)
- Subjects unable or unwilling to provide informed consent
- Any condition which precludes the subject's ability to comply with the study requirements
- 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 another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
- Patients with a serious medical condition and life expectancy of less than one year.
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 |
|---|---|---|
| Subcutaneous Implantable Defibrillator (S-ICD) System | Device | Subcutaneous implantable cardioverter defibrillator (S-ICD) System |
Primary outcome
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion
Time frame: 30 days
Sustained ventricular fibrillation induced by the investigator is successfully converted. A successful conversion was defined as two consecutive successful shocks out of four attempts with either standard polarity or with reverse polarity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20463331Bardy GH, Smith WM, Hood MA, Crozier IG, Melton IC, Jordaens L, Theuns D, Park RE, Wright DJ, Connelly DT, Fynn SP, Murgatroyd FD, Sperzel J, Neuzner J, Spitzer SG, Ardashev AV, Oduro A, Boersma L, Maass AH, Van Gelder IC, Wilde AA, van Dessel PF, Knops RE, Barr CS, Lupo P, Cappato R, Grace AA. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med. 2010 Jul 1;363(1):36-44. doi: 10.1056/NEJMoa0909545. Epub 2010 May 12.
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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.
Stephen O'Connor, PhD, Hon FRACP study director
Boston Scientific Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcutaneous Implantable Defibrillator (S-ICD) System in people with Ventricular Tachyarrhythmias, run by Boston Scientific Corporation at 2 sites in New Zealand.
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 4 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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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 29 Jun 2021). 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?
Number of Participants With a Successful Induced Ventricular Fibrillation Conversion (time frame: 30 days). 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 NCT00853645, which also lists 1 linked publication.
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 6 Jul 2021.