Acute Defibrillation Study

Study Overview
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Brief Summary
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The proposed study is designed to characterize defibrillation efficacy in humans for the potential development of a new extravascular implantable cardioverter defibrillator (ICD) system.

Detailed Description
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The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure. The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care. Subjects were followed through their routine post-surgery follow-up visit. At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.

Conditions
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Ventricular Arrhythmias

Intervention / Treatment
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* Device: Defibrillation following induction of VT/VF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be undergoing surgical procedure for approved indications for cardiothoracic surgery where a midline sternotomy is planned, or implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or VT ablation procedure, or VT inducibility testing during Electrophysiology (EP) study Subject must be willing to provide Informed Consent Subject must be ≥ 18 years old Exclusion Criteria: Subject is considered to be at high risk for infection Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20% Subject at high risk of stroke Subject with an implanted active cardiac or non-cardiac device during study procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator) Subject is pacemaker dependent Subject had previous pericarditis or prior sternotomy Subject has hiatus hernia or moderate or worse pectus excavatum Subject has hypertrophic cardiomyopathy Subject has severe aortic stenosis Subject has severe proximal three vessel coronary disease (over 70% in each vessel) Subject has >50% left main stem (LMS) disease Subject has known skin irritations to the Physio Control Fast Patch ECG Electrode 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 medical conditions that would limit study participation Subject is pregnant Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VT/VF induction and defibrillation<br>Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures. | Device: Defibrillation following induction of VT/VF<br>* Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defibrillation Outcome | Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system. | Day of procedure |