Non-vascular ICD Electrode Configuration Feasibility Study

Overview

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.

Full Title of Study: “Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 7, 2021

Interventions

  • 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.
  • Procedure: 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.
  • Procedure: 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.
  • Procedure: Removal of defibrillation coils and pulse generator
    • Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.

Arms, Groups and Cohorts

  • Experimental: Configuration A first
    • Subjects receive the test of Configuration A first and Configuration B second.
  • Experimental: Configuration B first
    • Subjects receive the test of Configuration B first and Configuration A second.

Clinical Trial Outcome Measures

Primary Measures

  • The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations
    • Time Frame: During the study procedure
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Reinoud E Knops, MD, PhD, Principal Investigator, Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands

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