Clinical trial NCT04809701: Non-vascular ICD Electrode Configuration Feasibility Study
Official title: Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Arrythmia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
timeFrame: During the study procedure
Secondary outcomes:
Other outcomes:
measure: The number of acute adverse events associated with the temporary implant and defibrillation testing with the two NV-ICD electrode configurations under investigation
timeFrame: Within 1 month of the study procedure
Locations:
city: Concepción
country: Chile
facility: Hospital Clínico Regional de Concepción
state: Bio Bio
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Asunción
country: Paraguay
facility: Centro de Intervenciones Endovasculares y Cirugía Cardiovascular
state: Distrito Capital
Study officials:
affiliation: Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands
name: Reinoud E Knops, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: