Non-vascular ICD Electrode Configuration Feasibility Study

Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Arrythmia
• Intervention / Treatment: Procedure: Temporary implantation of defibrillation coils and pulse generator; Procedure: Defibrillation following induction of VA (Configuration A first); Procedure: Removal of defibrillation coils and pulse generator; Procedure: Defibrillation following induction of VA (Configuration B first)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Bio Bio
    • Concepción, Bio Bio, Chile
      • Hospital Clínico Regional de Concepción
• Czechia
  • Prague, Czechia, 15000
    • Na Homolce Hospital
• Paraguay
  • Distrito Capital
    • Asunción, Distrito Capital, Paraguay
      • Centro de Intervenciones Endovasculares y Cirugia Cardiovascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Configuration A first; Subjects receive the test of Configuration A first and Configuration B second.	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: Removal of defibrillation coils and pulse generator; Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
Experimental: Configuration B first; Subjects receive the test of Configuration B first and Configuration A second.	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: Removal of defibrillation coils and pulse generator; Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Reinoud E Knops, MD, PhD, Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: ABT-CIP-10369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No