Ventricular ArrhythmiasNCT02227121
Acute Defibrillation Study
A study testing Defibrillation following induction of VT/VF in people with Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 7 sites in 4 countries.
Trial summary
The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias
- What is being tested?
- Defibrillation following induction of VT/VF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Feb 2015to Dec 2015
- 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
- Subject must be undergoing surgical procedure for approved indications for
- cardiothoracic surgery where a midline sternotomy is planned, or
- implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or
- VT ablation procedure, or
- VT inducibility testing during Electrophysiology (EP) study
- Subject must be willing to provide Informed Consent
- Subject must be ≥ 18 years old
Who cannot join
- Subject is considered to be at high risk for infection
- Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20%
- Subject at high risk of stroke
- Subject with an implanted active cardiac or non-cardiac device during study procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- Subject is pacemaker dependent
- Subject had previous pericarditis or prior sternotomy
Show all 16Show fewer
- Subject has hiatus hernia or moderate or worse pectus excavatum
- Subject has hypertrophic cardiomyopathy
- Subject has severe aortic stenosis
- Subject has severe proximal three vessel coronary disease (over 70% in each vessel)
- Subject has >50% left main stem (LMS) disease
- Subject has known skin irritations to the Physio Control Fast Patch ECG Electrode
- Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- 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
7 sites in 4 countries.
7 sites in 4 countries
United Kingdom3 sites
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
King's College Hospital
London, SE5 9RS
Southampton General Hospital
Southampton, SO16 6YD
Netherlands2 sites
Academisch Medisch Centrum
Amsterdam
St. Antonius Ziekenhuis
Nieuwegein
Poland1 site
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202
About this study
The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.
Read the detailed description
The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure.
The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care.
Subjects were followed through their routine post-surgery follow-up visit.
At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.
- Conditions
- Ventricular Arrhythmias
- Being tested
- Defibrillation following induction of VT/VF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defibrillation following induction of VT/VFDevice
Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.
| Study group | Role | What they receive |
|---|---|---|
| VT/VF induction and defibrillation | Experimental | Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures. Receives: Device: Defibrillation following induction of VT/VF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defibrillation Outcome
Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completionOct 2015
- Study completionDec 2015
Why it stopped: Sufficient enrollments under current protocol for further development \& studies
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02227121
- Sponsor's protocol ID
- ASD Study
- Status last verified
- Dec 2016
- First submitted
- 22 Aug 2014
- Last updated
- 13 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Defibrillation Study
- ClinicalTrials.gov ID
- NCT02227121
- Acronym / sponsor ID
- ASD Study
- Conditions
- Ventricular Arrhythmias
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sufficient enrollments under current protocol for further development \& studies
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Aug 2014 (estimated)
- Results
- Posted 13 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.
Detailed description
The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure.
The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care.
Subjects were followed through their routine post-surgery follow-up visit.
At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VT/VF induction and defibrillation | Experimental | Device: Defibrillation following induction of VT/VFVentricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must be undergoing surgical procedure for approved indications for
- cardiothoracic surgery where a midline sternotomy is planned, or
- implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or
- VT ablation procedure, or
- VT inducibility testing during Electrophysiology (EP) study
Key exclusion criteria (16 listed)
- Subject is considered to be at high risk for infection
- Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20%
- Subject at high risk of stroke
- Subject with an implanted active cardiac or non-cardiac device during study procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- Subject is pacemaker dependent
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 |
|---|---|---|
| Defibrillation following induction of VT/VFUp to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator. | Device | VT/VF induction and defibrillation |
Primary outcome
Defibrillation Outcome
Time frame: Day of procedure
Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defibrillation following induction of VT/VF in people with Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 7 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 7 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Netherlands, Hong Kong, Poland. 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 13 Feb 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?
Defibrillation Outcome (time frame: Day of procedure). 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 13 Feb 2017.