ALIVE Expended Access - Clinical Study (ALIVE-EA)

Inclusion Criteria: 18 years old or older; LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar; LV Aneurysm/Scar Location: Defined as a scar involving septum and/or anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management; Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging; Left Ventricular Ejection Fraction < 45%; Left ventricular end-systolic volume index ≥50 mL/m2; Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy; Patient completed 6 Minute Walk Test and MLHF Quality of Life Questionnaire (can be performed at baseline visit); Patient is on adequate Guideline Directed Medical Therapy (GDMT); Subject or a legally authorized representative must provide written informed consent; Agree to required follow-up visits; and Female subject of childbearing potential does not plan pregnancy for at least one year following the index procedure. For a female of childbearing potential, a pregnancy test must be performed with negative results known within seven days prior to index procedure. Exclusion Criteria: Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 60 days prior to enrollment; Valvular heart disease, which in the opinion of the investigator, will require surgery; Functional Mitral Regurgitation greater than moderate (i.e. EROA>20mm sq.) and primary MR (including MR due to papillary muscle rupture); Need for coronary revascularization, in the opinion of the site investigator; Peak Systolic Pulmonary Arterial Pressure > 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale; Myocardial Infarction within 90 days prior to enrollment; Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology; Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission; Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac; Page 6 of 64 BioVentrix CIP-0067, Rev A Chronic renal failure with a serum creatinine >2.5 mg/dL and/or GFR<30ml/min; Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. Presence of significant ventricular arrhythmias Contraindication or inability to adhere to systemic anticoagulation; Known hypersensitivity or contraindication to device materials; Previous pericardiotomy or left thoracotomy; Pathology/previous surgery/radiation therapy of the right neck that would interfere with placement of a 14F delivery catheter; Prior open heart surgery or significant pericarditis; Calcified ventricular wall in the area of intended anchor implants as verified by cardiac imaging; Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by cardiac imaging that has not been adequately treated with anticoagulant. Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement.