Acute Defibrillation Performance of a Novel Can-less Shock Pathway

Study Overview
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Brief Summary
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Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.

Detailed Description
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The purpose of this study is to evaluate the operation, safety, and feasibility of the ISSD system in patients who require an ICD. An ISSD emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, and then entirely removed. The emulator is not a powered medical device. This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.

Official Title
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Acute Defibrillation Performance of a Novel Can-less Shock Pathway

Conditions
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Tachycardia

Intervention / Treatment
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* Device: ISSD emulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects meeting class 1, 2a or 2b indication for ICD implantation Age >18 32 > Body Mass Index (BMI) > 25 190 > Height > 165 cm 120 > Waist size > 90 cm Exclusion Criteria: Any condition that precludes the subject's ability to comply with the study requirements, including completion of the study Female who is pregnant or breastfeeding; Female who is of childbearing age who does not use reliable contraception methods (e.g. contraceptive pills, Intra-Uterine Device, estrogen-containing plasters) or had a positive pregnancy test An acute infection requiring antibiotics two weeks prior to surgery Participation in any other investigational study in the time ICD implantation is planned, unless there is written consent from the study sponsor; Use of the antiarrhythmic drug Amiodarone (Cordarone, Sedacoron, Adenosine or other drugs) in the last 6 months before participation in the clinical trial; Existence of large permanent electrodes (e.g. epicardial electrodes), more than 3 permanent endocardial electrodes or any other metal object implanted in the upper part of your body; Any of the following cardiac diseases: protracted New York Heart Association (NYHA) class III or IV heart failure , Left Ventricular Ejection Fraction (LVEF) < 20% or an enlarged or hypertrophied heart Pulmonary hypertension patient, either with a history of moderate or severe pulmonary hypertension or by estimated pulmonary pressure above 45 (by cardiac echo test). Chronic Obstructive Pulmonary Disease (COPD) patient that have been hospitalized in the last 12 months for COPD related reasons, require oxygen support or steroid based therapeutic support. Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29. Subjects with prior abdominal surgery in the upper abdomen, previous upper abdominal trauma or anatomical deformities of the chest or upper abdomen Subjects with known bleeding diathesis.

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: treatment<br>patients receiving ISSD emulator | Device: ISSD emulator<br>* induced tachy-arrhythmia to be terminated by ISSD emulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defibrillation Threshold (DFT) | lowest shock energy required to terminate tachy-arrhythmia | immediately following induce tachy-arrhythmia |