Sensing and Defibrillation With a Commercially Available ICD Coupled With a Parasternal Extravascular Lead (SECURE EV) Study (SECURE EV)

The SECURE EV Study is a prospective, multi-center, single-arm study without concurrent or historical controls. The objectives of the study are 1) to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant, and 2) to characterize sensing and conversion of induced VF up to 90 days post-implant.

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia; Ventricular Arrhythmia
• Intervention / Treatment: Device: AtaCor EV-ICD Lead

Detailed Description

The primary safety objective of the study is to characterize safety of the AtaCor EV-ICD Lead up to 90 days post-implant. The primary performance objective is to characterize sensing and conversion of induced VF up to 90 days post-implant.

Up to 3 Investigational Sites Worldwide will participate with up to 20 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires sub-chronic evaluation of the lead up to 90 days.

Subjects will receive a concomitant EV-ICD System, comprising the investigational EV-ICD Lead connected to a commercially available ICD. Prior to discharge, the EV-ICD will be programmed to monitor only to detect and store ventricular arrhythmias over the 90-day follow-up period.

After the EV-ICD System is removed (up to 90 days post-implant), the Subject will be followed for an additional 30 days then exit the study. The duration of study participation for an individual Subject is 120 ± 7 days. The study is expected to complete within 6 months of the first enrollment.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Sanatorio Italiano

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. At least 18 years old
2. Indicated for de novo or replacement ICD procedure

Exclusion Criteria:

1. NYHA IV functional class
2. BMI ≥ 35 kg/m2
3. Inotropic therapy in past 180 days
4. Subjects who require continual ventricular pacing
5. Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period.
6. Planned MRI within the study period
7. Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
8. Logistical or safety related circumstances that may prevent data collection or follow-up
9. Participation in any concurrent clinical study without prior written approval from the Sponsor

10. Inability to give an informed consent to participate in the Study

    Known prior history for any of the following:

11. Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum for the EV-ICD Dilator, EV-ICD Delivery Tool and EV-ICD Lead
12. Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
13. Median or partial sternotomy
14. Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
15. Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
16. Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure
17. Pericardial disease, pericarditis and mediastinitis
18. Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions
19. FEV1 < 1.0 Liter
20. Surgically corrected congenital heart disease (not including catheter-based procedures)
21. Allergies to the device materials as listed in the Instructions for Use (IFU)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AtaCor EV-ICD Lead System; Subjects implanted with the AtaCor EV-ICD Lead Model AC-7001	Device: AtaCor EV-ICD Lead; Subjects will receive the AtaCor EV-ICD Lead being evaluated in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ADEs	Incidence of Adverse Device Effects (ADEs)	Up to 120 days post-implant
Induced VF Conversion Success	Induced VF conversion success with ≥10 J safety margin 60-90 days post-implant	Up to 90 days post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest Defibrillation Conversion Energy	Lowest Defibrillation Conversion Energy (J) at implant with left mid-axillary PG location	Procedure
Induced VF Conversion Success - Implant	Induced VF conversion success rate at implant with left pectoral PG location	Procedure
Induced VF Conversion Success - 30 Days	Induced VF conversion success with ≥10 J safety margin at 30 days	Up to 30 days post-implant
Sensing and Detection of Ventricular Arrhythmias	Ability to automatically sense and detect induced and spontaneous ventricular arrhythmias	Up to 90 days post-implant
Detection Time for VT/VF	Detection time for spontaneous VT/VF episodes recorded during follow-up by the permanent TV-ICD System and concomitantly implanted investigational EV-ICD System	Up to 90 days post-implant
Detection Time and Time-to-Therapy	EV-ICD VF detection time and time-to-therapy	Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Capture Threshold	Pacing Capture Threshold (V)	Up to 90 days post-implant
Brady Pacing Electrical Performance: Pacing Impedance	Pacing Impedance (ohms)	Up to 90 days post-implant
Brady Pacing Electrical Performance: R-wave Amplitude	R-wave Amplitude (mV)	Up to 90 days post-implant

Collaborators and Investigators

• Sponsor: AtaCor Medical, Inc.
• Investigators: Principal Investigator: Martin C Burke, DO, AtaCor Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): September 21, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Extravascular; Ventricular Defibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: DOC-10181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No