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Completed

NCT Number: NCT04809701

Non-vascular ICD Electrode Configuration Feasibility Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Regional de Concepción, Concepción, Biobio, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Temporary implantation of defibrillation coils and pulse generator

Procedure

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)

Procedure

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)

Procedure

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

Procedure

Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.

Primary outcomes

  1. 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.

Other outcomes

  1. The number of acute adverse events associated with the temporary implant and defibrillation testing with the two NV-ICD electrode configurations under investigation

    Time frame: Within 1 month of the study procedure

    Descriptive outcome summarizing possible acute adverse events with the temporary implant and defibrillation testing

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 22, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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