Non-vascular ICD Electrode Configuration Feasibility Study

• ClinicalTrials.gov Identifier: NCT04809701
• Recruitment Status: Enrolling by invitation
• First Posted: March 22, 2021
• Last Update Posted: January 5, 2022
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ventricular Arrythmia	Procedure: Temporary implantation of defibrillation coils and pulse generator; Procedure: Defibrillation following induction of VA (Configuration A first); Procedure: Defibrillation following induction of VA (Configuration B first); Procedure: Removal of defibrillation coils and pulse generator	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Different Defibrillation Electrode Configurations for Development of a Non-vascular ICD
• Actual Study Start Date: March 22, 2021
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: August 31, 2022

Arms and Interventions

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: 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Chile

Hospital Clínico Regional de Concepción

Concepción, Bio Bio, Chile

Czechia

Na Homolce Hospital

Prague, Czechia, 15000

Paraguay

Centro de Intervenciones Endovasculares y Cirugía Cardiovascular

Asunción, Distrito Capital, Paraguay

Sponsors and Collaborators

Abbott Medical Devices

Investigators

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

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT04809701
• Other Study ID Numbers: ABT-CIP-10369
• First Posted: March 22, 2021
• Last Update Posted: January 5, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes