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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02772380




Registration number
NCT02772380
Ethics application status
Date submitted
27/04/2016
Date registered
13/05/2016
Date last updated
19/06/2018

Titles & IDs
Public title
Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
Scientific title
Acute Extravascular Defibrillation Study
Secondary ID [1] 0 0
U1111-1179-2213
Secondary ID [2] 0 0
ASD2
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tachycardia 0 0
Ventricular Arrhythmias 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Defibrillation following induction of VT/VF

Experimental: VT/ VF induction and defibrillation - 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.


Treatment: Devices: Defibrillation following induction of VT/VF
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes
Timepoint [1] 0 0
Day of procedure

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

1. Screening subjects at high risk for infection will be based on the local investigator judgment decision.
2. 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).
3. Screening will be based on the local investigator judgment decision.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Connecticut
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Maryland
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United States of America
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Minnesota
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Belgium
State/province [13] 0 0
Gent
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Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Kowloon
Country [19] 0 0
Hungary
State/province [19] 0 0
Budapest
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Netherlands
State/province [20] 0 0
Amsterdam
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Netherlands
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Maastricht
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Netherlands
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Nieuwegein
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New Zealand
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Christchurch
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Poland
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Kraków
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Poland
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Zabrze
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Spain
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Cordoba
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
State/province [29] 0 0
Liverpool
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United Kingdom
State/province [30] 0 0
London
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United Kingdom
State/province [31] 0 0
Oxford
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United Kingdom
State/province [32] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT02772380
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02772380