Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
NCT ID: NCT02772380
Last Updated: 2018-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2016-05-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
Study Groups
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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.
Defibrillation following induction of VT/VF
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
Interventions
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Defibrillation following induction of VT/VF
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Hartford Hospital
Hartford, Connecticut, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Iowa Heart Center
Des Moines, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mayo Clinic (Rochester MN)
Rochester, Minnesota, United States
Lourdes Cardiology Services
Cherry Hill, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
New York-Presbytarian Hospital / Well Cornell Medical Center
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
Raleigh Cardiology Associates
Raleigh, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Austin Hospital
Heidelberg, Victoria, Australia
Universitair Ziekenhuis Gent
Ghent, , Belgium
UZ Leuven - Campus Gasthuisberg
Leuven, , Belgium
Royal Columbian Hospital
New Westminster, British Columbia, Canada
London Health Sciences Centre - University Campus
London, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
Prince of Wales Hospital
Kowloon, , Hong Kong
Semmelweis University
Budapest, , Hungary
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
St. Antonius Ziekenhuis
Nieuwegein, , Netherlands
Christchurch Hospital
Christchurch, , New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, , Poland
Slaskie Centrum Chorob Serca
Zabrze, , Poland
Hospital Universitario Reina Sofia
Córdoba, , Spain
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
King's College of London
London, , United Kingdom
John Radcliffe Hospital Oxford
Oxford, , United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
Countries
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Other Identifiers
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U1111-1179-2213
Identifier Type: OTHER
Identifier Source: secondary_id
ASD2
Identifier Type: -
Identifier Source: org_study_id
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