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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ventricular Arrhythmia, Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
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* Device: AtaCor EV-ICD Lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Indicated for de novo or replacement ICD procedure Exclusion Criteria: NYHA IV functional class BMI ≥ 35 kg/m2 Inotropic therapy in past 180 days Subjects who require continual ventricular pacing Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads within the study period. Planned MRI within the study period Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure Logistical or safety related circumstances that may prevent data collection or follow-up Participation in any concurrent clinical study without prior written approval from the Sponsor Inability to give an informed consent to participate in the Study Known prior history for any of the following: 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 Uncontrolled paroxysmal, persistent or permanent atrial fibrillation Median or partial sternotomy Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the EV-ICD Lead insertion procedure Pericardial disease, pericarditis and mediastinitis Medical treatments, surgeries or conditions that increase the potential for pericardial adhesions FEV1 < 1.0 Liter Surgically corrected congenital heart disease (not including catheter-based procedures) Allergies to the device materials as listed in the Instructions for Use (IFU)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular Defibrillation, Extravascular