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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | patients receiving ISSD emulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISSD emulator | Device | induced tachy-arrhythmia to be terminated by ISSD emulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Defibrillation Threshold (DFT) | lowest shock energy required to terminate tachy-arrhythmia | immediately following induce tachy-arrhythmia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petr Neuzil, Prof. | Chief of Cardiology, Na Homolce Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolce | Prague | Czechia |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |