Ventricular ArrhythmiasASQNCT01771172
Acute Subcutaneous Defibrillation
An observational study of Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in 5 countries.
Trial summary
To assess the defibrillation efficacy of a subcutaneous defibrillation system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias
- How many people
- 50 participants
- Where
- 8 sitesin 5 countries
- Study dates
- May 2013to Jun 2014
- Phase
- Observational
- 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
Study population: Subjects may be either male or female, and must meet all of the inclusion criteria and none of the exclusion criteria of the study
Who may be able to join
- Subject must be undergoing implant of a commercially approved ICD system
- Subject must be willing to provide Informed Consent
- Subject must be > 18 years old
Who cannot join
- Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months)
- Subject has high risk of infection
- Subject has EF < 15%
- Subject at high risk of stroke
- having a device replacement
- Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
Show all 12Show fewer
- Subject is indicated for CRT
- Subject is pacemaker dependent
- Subject enrolled in a concurrent study that may confound the results of this study
- Subject has medical conditions that would limit study participation
- Subject is pregnant
- Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United Kingdom3 sites
Dudley Group NHS-Russells Hall Hospital
Dudley
King's College Hospital
London
Southhampton General Hospital
Southhampton
About this study
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
- Conditions
- Ventricular Arrhythmias
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
Measured: within the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionJun 2014
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.
- Other trials for Ventricular ArrhythmiasStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771172
- Sponsor's protocol ID
- ASQ
- Acronym
- ASQ
- Status last verified
- Oct 2016
- First submitted
- 16 Jan 2013
- Last updated
- 2 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Subcutaneous Defibrillation
- ClinicalTrials.gov ID
- NCT01771172
- Acronym / sponsor ID
- ASQ / ASQ
- Conditions
- Ventricular Arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Posted 2 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects may be either male or female, and must meet all of the inclusion criteria and none of the exclusion criteria of the study
Key inclusion criteria (3 listed)
- Subject must be undergoing implant of a commercially approved ICD system
- Subject must be willing to provide Informed Consent
- Subject must be > 18 years old
Key exclusion criteria (12 listed)
- Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months)
- Subject has high risk of infection
- Subject has EF < 15%
- Subject at high risk of stroke
- having a device replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.
Time frame: within the first day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in 5 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 3 inclusion and 12 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 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Netherlands, Belarus, Denmark, Slovakia. 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 2 Dec 2016). 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?
Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. (time frame: within the first day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2016.