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

Not Applicable

Completed

• Conditions: Ventricular Arrhythmia; Ventricular Tachycardia; Ventricular Fibrillation
• Interventions: Device: AtaCor EV-ICD Lead

• Registration Number: NCT05352776
• Lead Sponsor: AtaCor Medical, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Study Start: 2022-05-18
• Primary Completion: 2022-09-21
• Study Completion: 2022-10-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AtaCor EV-ICD Lead System	AtaCor EV-ICD Lead	Subjects implanted with the AtaCor EV-ICD Lead Model AC-7001

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanatorio Italiano; 🇵🇾 Asunción, Paraguay