Non-vascular ICD Electrode Configuration Feasibility Study

NCT04809701 | Completed

• 1 other identifier: ABT-CIP-10369
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

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.

Conditions

Ventricular Arrythmia

Outcome Measures

Primary Outcomes (1)

• 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 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

  Within 1 month of the study procedure

Study Arms (2)

Configuration A first

EXPERIMENTAL

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

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

Configuration B first

EXPERIMENTAL

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

Procedure: Temporary implantation of defibrillation coils and pulse generator; Procedure: Defibrillation following induction of VA (Configuration B first); Procedure: Removal of defibrillation coils and pulse generator

Interventions

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.

Configuration A first; Configuration B first

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.

Configuration A first

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.

Configuration B first

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.

Configuration A first; Configuration B first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Hospital Clínico Regional de Concepción

Concepción, Bio Bio, Chile

Location

Na Homolce Hospital

Prague, 15000, Czechia

Location

Centro de Intervenciones Endovasculares y Cirugía Cardiovascular

Asunción, Asunción, Paraguay

Location

Study Officials

• Reinoud E Knops, MD, PhD

  Academic Medical Center Department of Cardiology Meibergdreef 9 1105 AZ Amsterdam The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 22, 2021
• Study Start: March 22, 2021
• Primary Completion: December 7, 2021
• Study Completion: March 24, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1); CZ (1); PA (1)