BioVentrix Revivent TC™ System Clinical Study

Exclusion Criteria

• •Candidates will be excluded from the study and active concurrent control group if ANY of the following conditions are present:
• •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 degenerative 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;
• •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;