TachycardiaNCT02772380
Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
A study testing Defibrillation following induction of VT/VF in people with Tachycardia and Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 36 sites in 12 countries.
Trial summary
The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachycardia, 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
- 87 participants
- Where
- 36 sitesin 12 countries
- Study dates
- May 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- cardiothoracic surgery where a subxiphoid/paraxiphoid cut for a chest tube is planned, or
- VT ablation procedure with epicardial access, or
- implant of a subcutaneous ICD (S-ICD®), or implant of a transvenous ICD (single or dual chamber)
- Subject must be willing to provide Informed Consent
- Subject must be ≥ 18 years old
Who cannot join
- Subject has known hiatus hernia or moderate or worse pectus excavatum
- Subject had previous pericarditis or prior sternotomy
- Subject has known significant Right Ventricle/ Right Ventricular dilation
- Subject has hypertrophic cardiomyopathy
- Subject is pacemaker dependent
- Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
Show all 24Show fewer
- Subject is considered to be at high risk for infection(1)
- Subject has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months)
- Subject has New York Heart Association Class IV
- Subject has myocardial infarction within the last 6 weeks
- Subject currently has unstable angina
- Subject has severe aortic stenosis
- Subject at high risk of stroke (2)
- Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent
- Subject has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure (3)
- Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- 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 any medical condition that would limit study participation
- Subject is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to the ASD2 Acute Testing procedure
- Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
- Subject is legally incompetent
- Screening subjects at high risk for infection will be based on the local investigator judgment decision.
- Subjects who are at high risk for stroke should be screened according to local country guidelines or, in case of their absence, according to ACC/AHA/ESC 2006 Guidelines for High Risk Factors for Stroke (i.e. exclusion of subjects with previous stroke, TIA, or embolism; Mitral stenosis; prosthetic heart valve).
- Screening will be based on the local investigator judgment decision.
Trial locations and contacts
36 sites in 12 countries.
36 sites in 12 countries
United States14 sites
University of Maryland Medical Center
Baltimore, Maryland
Lourdes Cardiology Services
Cherry Hill, New Jersey
Northwestern University
Chicago, Illinois
The Ohio State University Wexner Medical Center
Columbus, Ohio
Iowa Heart Center
Des Moines, Iowa
Hartford Hospital
Hartford, Connecticut
Baptist Medical Center Jacksonville
Jacksonville, Florida
Lancaster General Hospital
Lancaster, Pennsylvania
Morristown Memorial Hospital
Morristown, New Jersey
New York-Presbytarian Hospital / Well Cornell Medical Center
New York, New York
NYU Langone Medical Center
New York, New York
Raleigh Cardiology Associates
Raleigh, North Carolina
Mayo Clinic (Rochester MN)
Rochester, Minnesota
Arizona Arrhythmia Consultants
Scottsdale, Arizona
United Kingdom4 sites
Liverpool Heart and Chest Hospital
Liverpool
King's College of London
London
John Radcliffe Hospital Oxford
Oxford
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton
Canada3 sites
London Health Sciences Centre - University Campus
London, Ontario
Royal Columbian Hospital
New Westminster, British Columbia
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec
Netherlands3 sites
Academisch Medisch Centrum (AMC)
Amsterdam
Maastricht Universitair Medisch Centrum
Maastricht
St. Antonius Ziekenhuis
Nieuwegein
Taiwan3 sites
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Belgium2 sites
Universitair Ziekenhuis Gent
Ghent
UZ Leuven - Campus Gasthuisberg
Leuven
Poland2 sites
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow
Slaskie Centrum Chorob Serca
Zabrze
About this study
Official title: Acute Extravascular Defibrillation Study
The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.
- Conditions
- Tachycardia, Ventricular Arrhythmias
- Being tested
- Defibrillation following induction of VT/VF
- Medical subject headings
- Tachycardia
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 attempts to induce two VF/VT episodes for defibrillation testing
| Study group | Role | What they receive |
|---|---|---|
| VT/ VF induction and defibrillation | Experimental | Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and termination through use of a defibrillator, will be carried out as the intervention 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.
Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
Collect extravascular EGMs during induced VF/VT and intrinsic rhythms directly from an investigational lead placed in the extravascular space to be used for development of a future ICD.
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 posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachycardiaStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects who are undergoing a standard of care procedure will also undergo the ASD2 research procedure involving placing an investigational lead in the substernal space to gather electrograms during induced ventricular arrhythmias for future research/development.
- Enrolment
- 87 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
- NCT02772380
- Sponsor's protocol ID
- ASD2
- Other IDs
- U1111-1179-2213
- Status last verified
- Mar 2018
- First submitted
- 27 Apr 2016
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Extravascular Defibrillation Study
- ClinicalTrials.gov ID
- NCT02772380
- Acronym / sponsor ID
- ASD2
- Conditions
- Tachycardia, Ventricular Arrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this clinical study is to collect electrograms from an investigational lead placed in an extravascular space, for development of a future Implantable Cardioverter Defibrillator (ICD) system.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
- Model description
- Subjects who are undergoing a standard of care procedure will also undergo the ASD2 research procedure involving placing an investigational lead in the substernal space to gather electrograms during induced ventricular arrhythmias for future research/development.
| Arm | Type | Receives |
|---|---|---|
| VT/ VF induction and defibrillation | Experimental | Device: Defibrillation following induction of VT/VFVentricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and termination through use of a defibrillator, will be carried out as the intervention 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:
- Subject must be willing to provide Informed Consent
- Subject must be ≥ 18 years old
Key exclusion criteria (24 listed)
- Subject has known hiatus hernia or moderate or worse pectus excavatum
- Subject had previous pericarditis or prior sternotomy
- Subject has known significant Right Ventricle/ Right Ventricular dilation
- Subject has hypertrophic cardiomyopathy
- 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 attempts to induce two VF/VT episodes for defibrillation testing | Device | VT/ VF induction and defibrillation |
Primary outcome
Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
Time frame: Day of procedure
Collect extravascular EGMs during induced VF/VT and intrinsic rhythms directly from an investigational lead placed in the extravascular space to be used for development of a future ICD.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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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.
36 sites in 12 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 Tachycardia and Ventricular Arrhythmias, run by Medtronic Cardiac Rhythm and Heart Failure at 36 sites in 12 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 24 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, United Kingdom, Canada, Netherlands, Taiwan and 7 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes (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 19 Jun 2018; AzTrials last refreshed its copy on 31 Oct 2026.