Non-vascular ICD Electrode Configuration Feasibility Study

Not Applicable

Completed

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

• Registration Number: NCT04809701
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-18
• Study Start: 2021-03-22
• Study First Posted: 2021-03-22
• Primary Completion: 2021-12-07
• Study Completion: 2022-03-24
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Configuration B first	Removal of defibrillation coils and pulse generator	Subjects receive the test of Configuration B first and Configuration A second.
Configuration A first	Removal of defibrillation coils and pulse generator	Subjects receive the test of Configuration A first and Configuration B second.
Configuration A first	Temporary implantation of defibrillation coils and pulse generator	Subjects receive the test of Configuration A first and Configuration B second.
Configuration B first	Temporary implantation of defibrillation coils and pulse generator	Subjects receive the test of Configuration B first and Configuration A second.
Configuration B first	Defibrillation following induction of VA (Configuration B first)	Subjects receive the test of Configuration B first and Configuration A second.
Configuration A first	Defibrillation following induction of VA (Configuration A first)	Subjects receive the test of Configuration A first and Configuration B second.

Primary Outcome Measures

Name	Time	Method
The rate of successful defibrillation of induced VA using each of the two NV-ICD electrode configurations	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.

Trial Locations

Locations (3)

Centro de Intervenciones Endovasculares y Cirugía Cardiovascular; 🇵🇾 Asunción, Distrito Capital, Paraguay

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Hospital Clínico Regional de Concepción; 🇨🇱 Concepción, Bio Bio, Chile