Acute Study to Collect Electrical Signals From the Heart Using a Special Lead
- Conditions
- TachycardiaVentricular Arrhythmias
- Interventions
- Device: Defibrillation following induction of VT/VF
- Registration Number
- NCT02772380
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
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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)
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Subject must be willing to provide Informed Consent
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Subject must be ≥ 18 years old
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Subject has known hiatus hernia or moderate or worse pectus excavatum
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Subject had previous pericarditis or prior sternotomy
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Subject has known significant Right Ventricle/ Right Ventricular dilation
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Subject has hypertrophic cardiomyopathy
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Subject is pacemaker dependent
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Subject has known skin irritations due to the Covidien Multi-function defibrillation electrode
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Subject is considered to be at high risk for infection(1)
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Subject has Left Ventricular Ejection Fraction < 20% (most recent available LVEF measurement in the last 6 months)
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Subject has New York Heart Association Class IV
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Subject has myocardial infarction within the last 6 weeks
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Subject currently has unstable angina
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Subject has severe aortic stenosis
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Subject at high risk of stroke (2)
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Subject has Chronic Obstructive Pulmonary Disease and is oxygen dependent
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Subject has permanent AF and will not be adequately anticoagulated during the ASD2 Acute Testing procedure (3)
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Subject with an implanted active cardiac or non-cardiac device during the ASD2 Acute Testing procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
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Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
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Subject has any medical condition that would limit study participation
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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
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Subject meets exclusion criteria required by local law (e.g. age, breast feeding,etc.)
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VT/ VF induction and defibrillation Defibrillation following induction of VT/VF 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.
- Primary Outcome Measures
Name Time Method Number of extravascular electrograms collected during ventricular fibrillation or ventricular tachycardia episodes 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Northwestern University
🇺🇸Chicago, Illinois, United States
Baptist Medical Center Jacksonville
🇺🇸Jacksonville, Florida, 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
New York-Presbytarian Hospital / Well Cornell 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
Christchurch Hospital
🇳🇿Christchurch, New Zealand
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom
John Radcliffe Hospital Oxford
🇬🇧Oxford, United Kingdom
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
King's College of London
🇬🇧London, United Kingdom
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
London Health Sciences Centre - University Campus
🇨🇦London, Ontario, Canada
NYU Langone Medical Center
🇺🇸New York, New York, United States
Academisch Medisch Centrum (AMC)
🇳🇱Amsterdam, Netherlands
Krakowski Szpital Specjalistyczny im. Jana Pawla II
🇵🇱Kraków, Poland
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Semmelweis University
🇭🇺Budapest, Hungary
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Slaskie Centrum Chorob Serca
🇵🇱Zabrze, Poland
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Arizona Arrhythmia Consultants
🇺🇸Scottsdale, Arizona, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
UZ Leuven - Campus Gasthuisberg
🇧🇪Leuven, Belgium
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
🇨🇦Quebec City, Quebec, Canada
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Lourdes Cardiology Services
🇺🇸Cherry Hill, New Jersey, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Maastricht Universitair Medisch Centrum
🇳🇱Maastricht, Netherlands
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Prince of Wales Hospital
🇭🇰Kowloon, Hong Kong