Tachycardia, Ventricular Arrhythmias
Conditions
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.
Interventions
Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Belgium, Canada, Hong Kong, Hungary, Netherlands, New Zealand, Poland, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed