Temporary implantation of defibrillation coils and pulse generator
ProcedureEach subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.
NCT Number: NCT04809701
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hospital Clínico Regional de Concepción, Concepción, Biobio, Chile
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.
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.
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.
Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
Time frame: During the study procedure
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.
Time frame: Within 1 month of the study procedure
Descriptive outcome summarizing possible acute adverse events with the temporary implant and defibrillation testing
Abbott Medical Devices
Industry
Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
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