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

AtaCor Medical

Status

Completed

Conditions

Ventricular Fibrillation

Ventricular Arrhythmia

Ventricular Tachycardia

Treatments

Device: AtaCor EV-ICD Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT05099289

DOC-10154

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)