Study Status: 
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:

  1. Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment;
  2. Peak Systolic Pulmonary Arterial Pressure > 60 mm Hg via echo or RHC and/or evidence of cor pulmonale
  3. Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology
  4. Chronic renal failure with a serum creatinine >2.5 mg/dL and/or GFR<30ml/min
Principal Investigator: 
Evelun Horn, MD

PI: Evelyn Horn, MD (646) 962 5555

RC:  Katelyn Bastert,  (212) 746 2698

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Division of Cardiology

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New York, NY 10021