Study Status:
Open
Study Description:
Left Ventricular Aneurysm
Study Name: ALIVE
Study Objective: To evaluate safety/efficacy of a new device, called the BioVentrix Revivent TC System, designed to treat LVA.
Key Inclusion Criteria:
- Age 18 – 80
- LVEF < 45%
- NYHA Class > 2 not responsive to medical therapy
- LV Aneurysm/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 anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management
Key Exclusion Criteria:
- Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment;
- Peak Systolic Pulmonary Arterial Pressure > 60 mm Hg via echo or RHC and/or evidence of cor pulmonale
- Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology
- Chronic renal failure with a serum creatinine >2.5 mg/dL and/or GFR<30ml/min
Principal Investigator:
Evelun Horn, MD
Contact:
PI: Evelyn Horn, MD (646) 962 5555
RC: Katelyn Bastert, (212) 746 2698