Assessment of a Chronically Implanted Parasternally Delivered EV-ICD Lead (ASCEND EV) Study

Ki vehet részt

• At least 18 years old
• Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines

Ki nem vehet részt

• Participation in any concurrent clinical study without prior written approval from the Sponsor
• Subjects on anticoagulation therapy that cannot be temporarily discontinued for the procedure
• Implanted with or planned implantation of any device which delivers current in the body, that may interfere with therapy delivery, including, but not limited to a pacemaker, or neurostimulator
• Prior sternotomy of any type, including but not limited to median, mini or clamshell
• Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
• Inotropic therapy in past 180 days
• Any known conditions which may complicate the AtaCor EV-ICD Lead System implant procedure or prevent the subject from completing protocol testing through the 3-month follow-up visit
• Allergies to any device materials listed in the Instructions for Use (IFU)
• Known history of lung disease with FEV1 < 1.0 Liter; Device Related:
• Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
• Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis) and associated with displacement of the heart or lungs or impeded mediastinal access
• History of thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments/conditions which may complicate the AtaCor EV-ICD Lead System implant procedure
• Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
• Surgically corrected congenital heart disease (not including catheter-based procedures); Cardiac Related:
• Subjects who require permanent bradycardia pacing or cardiac resynchronization therapy
• Known history of pericardial disease, pericarditis or mediastinitis
• Patients with a medical condition that precludes them from undergoing defibrillation testing:; Severe aortic stenosis; Current Intracardiac LA or LV thrombus; Severe proximal three-vessel or left main coronary artery disease without revascularization; Hemodynamic instability; Unstable angina; Recent stroke or transient ischemic attack (within the last 6 months); Known inadequate external defibrillation; LVEF < 20%; LVEDD >70 mm
• Inability or unwillingness to provide informed consent to participate in the Study
• Circumstances that may prevent data collection or completion of specified follow-up visits
• Presence or planned use of medical devices that introduce current into the body (e.g., pacemaker, LVAD, neurostimulator, etc.)
• Presence or planned use of a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
• Any known need for future MRI; Anatomy Related:
• BMI ≥ 35 kg/m2
• NYHA IV functional class in past 90 days