Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System

The Continued Access study is a prospective, non-randomized, multi-center study designed to
allow controlled access to the Optimizer Smart System until the PMA order has been issued by
the FDA.

Inclusion Criteria:

1. Subjects who are 18 years of age or older

2. Subjects who have a baseline ejection fraction greater than or equal to 25% and less
than or equal to 45% by echocardiography.

3. Subjects who, in the opinion of the Investigator (based on the current guidelines for
clinical practice), have been treated for heart failure for at least 90 days and are
currently receiving appropriate, stable medical therapy during the 30 days prior to
enrollment for treatment of heart failure.

4. Subjects who are in New York Heart Association functional Class III and IV at the time
of enrollment.

5. Subjects who are willing and able to return for all follow-up visits.

Exclusion Criteria:

1. Subjects who have a potentially correctible cause of heart failure, such as valvular
heart disease or congenital heart disease.

2. Subjects receiving any form of inotropic support within 30 days before enrollment,
including subjects on continuous IV inotrope therapy.

3. Subjects hospitalized for decompensated heart failure requiring acute treatment with
intravenous loop diuretics, IV inotropes or hemofiltration within 30 days before
enrollment and baseline testing.

4. Subjects who have a clinically significant amount of ambient ectopy, defined as more
than 8,900 PVCs per 24 hours on baseline Holter monitoring.

5. Subjects having a PR interval greater than 375ms.

6. Subjects who have chronic (permanent or persistent) atrial fibrillation or atrial
flutter or those cardioverted within 30 days of enrollment.

7. Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a
CABG procedure within 90 days or a PTCA procedure within 30 days of enrollment.

8. Subjects who have a biventricular pacing system, an accepted indication for such a
device, or a QRS width of 130ms or greater.

9. Subjects who have had a myocardial infarction within 90 days of enrollment.

10. Subjects who have mechanical tricuspid valve.

11. Subjects who have a Left Ventricular Assist Device or prior heart transplant.

12. Subjects on dialysis.

13. Subjects who are participating in another experimental protocol.

14. Subjects who are unable to provide informed consent.