A pivotal trial dedicated to helping those with
heart failure.

Paracor Medical, Inc. has received permission from the FDA to begin a randomized, prospective, multi-center clinical research trial to compare the investigational HeartNet™ Ventricular Support System with optimal medical and device therapy (Treatment Group) to optimal medical and device therapy alone (Control Group) in the treatment of symptomatic heart failure caused by ischemic or non-ischemic dilated cardiomyopathy.

Patients with heart failure who meet the screening inclusion/exclusion criteria will be considered for enrollment in the trial. After obtaining informed consent, patients fulfilling the screening criteria will undergo additional tests to determine their eligibility for participation in the study. Pre-randomization tests and assessments will include:

• History and physical exam;
• NYHA Functional Class;
• Pulmonary function test
• Transthoracic echocardiography;
• Blood tests (BUN, Creatinine, SGOT, SGPT, Hgb, Hct. If creatinine is >1.5, then GFR or creatinine clearance must be done);
• Quality of life assessments
• Six-minute walk test(s);
• Cardiopulmonary exercise test(s)

Upon determination of eligibility, patients will be randomized to either the Treatment Group or the Control Group. Patients enrolled in the Treatment Group will receive a HeartNet implant and continue to receive optimal medical and device therapy. Those enrolled in the Control Group will NOT receive an implant, but will continue to receive optimal medical and device therapy under the care of a heart failure specialist associated with this study.

Follow up with a physician or nurse will occur at months 3, 6, and 12, then every 12 months thereafter for 5 years.

Subjects will be withdrawn from the trial if they withdraw their consent or are withdrawn upon the recommendation of their physician.