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

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

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

• 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.