Non-vascular ICD Electrode Configuration Feasibility Study

Study Overview
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Brief Summary
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This study is designed to evaluate the energy requirements of two different Nonvascular ICD (NV-ICD) electrode configurations for achieving successful defibrillation of ventricular arrhythmias.

Official Title
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Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD

Conditions
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Ventricular Arrythmia

Intervention / Treatment
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* Procedure: Temporary implantation of defibrillation coils and pulse generator
* Procedure: Defibrillation following induction of VA (Configuration A first)
* Procedure: Defibrillation following induction of VA (Configuration B first)
* Procedure: Removal of defibrillation coils and pulse generator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines Patient must be at least 18 years of age Subject must provide written informed consent prior to any clinical investigation-related procedure. Exclusion Criteria: Pacemaker dependency Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current Currently taking amiodarone or a Class IC antiarrhythmic drug Hypertrophic cardiomyopathy Anticipated high risk of stroke Anticipated high surgical risk or risk of infection Severe aortic stenosis Severe proximal three vessel coronary disease (over 70% in each vessel) Greater than 50% left main stem disease Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion Medical conditions that preclude defibrillation testing Chronic renal insufficiency including patients on dialysis Subject is currently participating in another clinical investigation. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Configuration A first<br>Subjects receive the test of Configuration A first and Configuration B second. | Procedure: Temporary implantation of defibrillation coils and pulse generator<br>* Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.<br>Procedure: Defibrillation following induction of VA (Configuration A first)<br>* Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration A. Then up to two defibrillation energies will be tested for Configuration B.<br>Procedure: Removal of defibrillation coils and pulse generator<br>* Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.<br>|
| Experimental: Configuration B first<br>Subjects receive the test of Configuration B first and Configuration A second. | Procedure: Temporary implantation of defibrillation coils and pulse generator<br>* Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.<br>Procedure: Defibrillation following induction of VA (Configuration B first)<br>* Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration B. Then up to two defibrillation energies will be tested for Configuration A.<br>Procedure: Removal of defibrillation coils and pulse generator<br>* Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations | Successful defibrillation is defined as termination of the induced VA to sinus rhythm or other non-life threatening ventricular or escape rhythm (such as atrial fibrillation) as determined by the implanting physician. | During the study procedure |