Ventricular Arrythmia Clinical Trial
Official title:
Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
Verified date | October 2022 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 24, 2022 |
Est. primary completion date | December 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patient that is scheduled to undergo surgery requiring midline sternotomy or implantation of a commercially-available TV-ICD or S-ICD system per local guidelines 2. Patient must be at least 18 years of age 3. Subject must provide written informed consent prior to any clinical investigation-related procedure. Exclusion Criteria: 1. Pacemaker dependency 2. Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current 3. Currently taking amiodarone or a Class IC antiarrhythmic drug 4. Hypertrophic cardiomyopathy 5. Anticipated high risk of stroke 6. Anticipated high surgical risk or risk of infection 7. Severe aortic stenosis 8. Severe proximal three vessel coronary disease (over 70% in each vessel) 9. Greater than 50% left main stem disease 10. Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion 11. Medical conditions that preclude defibrillation testing 12. Chronic renal insufficiency including patients on dialysis 13. Subject is currently participating in another clinical investigation. 14. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. 15. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with the 1-month phone follow-up requirements of the clinical investigation results. |
Country | Name | City | State |
---|---|---|---|
Chile | Hospital Clínico Regional de Concepción | Concepción | Bio Bio |
Czechia | Na Homolce Hospital | Prague | |
Paraguay | Centro de Intervenciones Endovasculares y Cirugía Cardiovascular | Asunción | Distrito Capital |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
Chile, Czechia, Paraguay,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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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