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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Configuration A first | Experimental | Subjects receive the test of Configuration A first and Configuration B second. |
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| Configuration B first | Experimental | Subjects receive the test of Configuration B first and Configuration A second. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary implantation of defibrillation coils and pulse generator | Procedure | Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations. |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| The number of acute adverse events associated with the temporary implant and defibrillation testing with the two NV-ICD electrode configurations under investigation | Descriptive outcome summarizing possible acute adverse events with the temporary implant and defibrillation testing | Within 1 month of the study procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reinoud E Knops, MD, PhD | Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Regional de Concepción | Concepción | Biobio | Chile | |||
| Na Homolce Hospital |
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| Defibrillation following induction of VA (Configuration A first) | Procedure | 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. |
|
| Defibrillation following induction of VA (Configuration B first) | Procedure | 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. |
|
| Removal of defibrillation coils and pulse generator | Procedure | Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed. |
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| Prague |
| 15000 |
| Czechia |
| Centro de Intervenciones Endovasculares y Cirugía Cardiovascular | Asunción | Asuncion | Paraguay |