30
Participants
Start Date
March 22, 2021
Primary Completion Date
December 7, 2021
Study Completion Date
March 24, 2022
Temporary implantation of defibrillation coils and pulse generator
Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.
Defibrillation following induction of VA (Configuration A first)
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)
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
Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
Na Homolce Hospital, Prague
Hospital Clínico Regional de Concepción, Concepción
Centro de Intervenciones Endovasculares y Cirugía Cardiovascular, Asunción
Lead Sponsor
Abbott Medical Devices
INDUSTRY