Acute Study to Collect Electrical Signals From the Heart Using a Special Lead

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 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.