Non-vascular ICD Electrode Configuration Feasibility Study

Ventricular Arrythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809701
• Other study ID #: ABT-CIP-10369
• Status: Completed
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: March 24, 2022

Study information

• Verified date: October 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 24, 2022
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Ventricular Arrythmia

Intervention

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

Locations

Country	Name	City	State
Chile	Hospital Clínico Regional de Concepción	Concepción	Bio Bio
Czechia	Na Homolce Hospital	Prague
Paraguay	Centro de Intervenciones Endovasculares y Cirugía Cardiovascular	Asunción	Distrito Capital

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Chile,  Czechia,  Paraguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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