Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study

Ki vehet részt

• At least 18 years old
• Indicated for de novo or replacement ICD procedure

Ki nem vehet részt

• Subjects on anticoagulation or antiplatelet therapy that cannot be temporarily discontinued for the procedure
• Participation in any concurrent clinical study without prior written approval from the Sponsor
• Inability or unwillingness to provide informed consent to participate in the Study; Known prior history for any of the following:
• Inotropic therapy in past 180 days
• Surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium
• Thoracic radiation therapy, pneumothorax, pneumomediastinum or other medical treatments which may complicate the AtaCor EV-ICD Lead System implant procedure
• Structural abnormalities of the heart that may increase risk of the study procedure or an obstructed/restricted pathway into the mediastinum
• Any conditions which may complicate the AtaCor EV-ICD Lead System implant procedure
• Pericardial disease, pericarditis and mediastinitis
• Medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
• Surgically corrected congenital heart disease (not including catheter-based procedures)
• Allergies to the device materials as listed in the Instructions for Use (IFU)
• BMI ≥ 35 kg/m2
• 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
• Circumstances that may prevent data collection or follow-up
• NYHA IV functional class in past 90 days
• Uncontrolled paroxysmal, persistent or permanent atrial fibrillation
• Median or partial sternotomy
• Significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
• FEV1 < 1.0 Liter