Status:
COMPLETED
Non-vascular ICD Electrode Configuration Feasibility Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Ventricular Arrythmia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Eligibility Criteria
Inclusion
- 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
- Patient must be at least 18 years of age
- Subject must provide written informed consent prior to any clinical investigation-related procedure.
Exclusion
- Pacemaker dependency
- Chronically implanted cardiac implantable electronic device or other device which delivers an electrical current
- Currently taking amiodarone or a Class IC antiarrhythmic drug
- Hypertrophic cardiomyopathy
- Anticipated high risk of stroke
- Anticipated high surgical risk or risk of infection
- Severe aortic stenosis
- Severe proximal three vessel coronary disease (over 70% in each vessel)
- Greater than 50% left main stem disease
- Prior surgery or anatomical abnormality that significantly increases implant risk per physician's discretion
- Medical conditions that preclude defibrillation testing
- Chronic renal insufficiency including patients on dialysis
- Subject is currently participating in another clinical investigation.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04809701
Start Date
March 22 2021
End Date
March 24 2022
Last Update
October 12 2022
Active Locations (3)
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1
Hospital Clínico Regional de Concepción
Concepción, Bio Bio, Chile
2
Na Homolce Hospital
Prague, Czechia, 15000
3
Centro de Intervenciones Endovasculares y Cirugía Cardiovascular
Asunción, Asunción, Paraguay