ALIVE Expended Access - Clinical Study

Exclusion Criteria

• •1. Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 60 days prior to enrollment;
• •2. Valvular heart disease, which in the opinion of the investigator, will require surgery;
• •3. Functional Mitral Regurgitation greater than moderate (i.e. EROA\>20mm sq.) and primary MR (including MR due to papillary muscle rupture);
• •4. Need for coronary revascularization, in the opinion of the site investigator;
• •5. Peak Systolic Pulmonary Arterial Pressure \> 60 mm Hg via echo or right heart catheterization and/or evidence of cor pulmonale;
• •6. Myocardial Infarction within 90 days prior to enrollment;
• •7. Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology;
• •8. Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission;
• •9. 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
• •10. Chronic renal failure with a serum creatinine \>2.5 mg/dL and/or GFR\<30ml/min;
• •11. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• •12. Presence of significant ventricular arrhythmias
• •13. Contraindication or inability to adhere to systemic anticoagulation;
• •14. Known hypersensitivity or contraindication to device materials;
• •15. Previous pericardiotomy or left thoracotomy;
• •16. Pathology/previous surgery/radiation therapy of the right neck that would interfere with placement of a 14F delivery catheter;
• •17. Prior open heart surgery or significant pericarditis;
• •18. Calcified ventricular wall in the area of intended anchor implants as verified by cardiac imaging;
• •19. Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by cardiac imaging that has not been adequately treated with anticoagulant.
• •20. Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement.