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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04809701
Other study ID # ABT-CIP-10369
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2021
Est. completion date March 24, 2022

Study information

Verified date October 2022
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Chile,  Czechia,  Paraguay, 

Outcome

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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