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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1179-2213 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillation following induction of VT/VF | Device | Up to 10 attempts to induce two VF/VT episodes for defibrillation testing |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day of procedure |
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Inclusion Criteria:
Subject must be undergoing surgical procedure for approved indications for:
Subject must be willing to provide Informed Consent
Subject must be ≥ 18 years old
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arrhythmia Consultants | Scottsdale | Arizona | United States | |||
| Hartford Hospital |
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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.
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| 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 |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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