Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study

Study Overview
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Brief Summary
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The PASS PULL EV-ICD Study is a prospective, multi-center, single-arm study without concurrent or historical controls. This initial concept feasibility study is primarily intended to demonstrate that the EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the AtaCor delivery system. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation.

Detailed Description
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The primary objective of the study is to demonstrate that the AtaCor EV-ICD Lead can be safely positioned within the anterior mediastinum as intended using the EV-ICD Dilator and EV-ICD Delivery Tool. The study will secondarily characterize the ability for the EV-ICD Lead to facilitate VF sensing and defibrillation. Up to 3 Investigational Sites will participate with up to 65 subjects enrolled in the study. Patients undergoing de novo or replacement ICD procedure will be eligible for participation. Study participation requires acute evaluation of the EV-ICD Lead during the index procedure. Echocardiography will be used to evaluate any new or worsening pericardial effusions. A follow-up visit will occur 7-10 days post-removal via phone, video call, or in-person. Participation will end after completion of the 7-10 days post-removal visit. The Study is expected to last up to 3 months for enrollment.

Official Title
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Parasternal Access for ShockS and Pacing With an acUtely Placed Less-invasive Lead for EV-ICD (PASS PULL EV-ICD) Study

Conditions
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Ventricular Tachycardia, Ventricular Arrhythmia, 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 with a hemodynamically unstable intrinsic heart rate that requires continual ventricular pacing Presence or planned use of subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads Subjects on anticoagulation/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 as assessed from available CT or Echocardiography. 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: Basic Science
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 inserted with the AtaCor EV-ICD Lead Model AC-7000 | 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 SADEs | Incidence of Serious Adverse Device Effects (SADEs) | Up to 10 days post-procedure | 
| Rate of Insertion Success | Defined as the ability to deploy the lead in a position within the mediastinum that is suitable for defibrillation testing and does not result in one (1) or more SADEs | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality - Lowest Defibrillation Conversion Energy | Lowest Defibrillation Conversion Energy (J) | Procedure | 
| Observational: Incidence of ADEs | Incidence of Adverse Device Effects (ADEs), Overall and Individual | Up to 10 days post-procedure | 

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