Evaluate Safety and Efficacy of the OPTIMIZER® System in Subjects With Moderate-to-Severe Heart Failure: FIX-HF-5C

The Impulse Dynamics FIX-HF-5C Study is a prospective, multicenter, randomized study to
evaluate the safety and efficacy of cardiac contractility modulation (CCM) signals delivered
by the implantable OPTIMIZER System in patients with NYHA class III and IV heart failure and
an ejection fraction 25-45%. The study will involve the recruitment of 160 subjects at a
total of up to 60 sites.

Those subjects who fulfill all inclusion and exclusion criteria based upon baseline test
results will be randomly assigned in a 1:1 ratio to either the OPTIMIZER System plus optimal
medical therapy (OMT) or to a control group receiving OMT alone. All randomized subjects will
be followed for 24 weeks and shall receive the same study related assessments throughout the
course of the study. In addition, all subjects will continue to receive OMT for the treatment
of their heart failure. Mortality will be reported out to 2 years.

Inclusion Criteria:

1. Subjects who are 18 years of age or older

2. Subjects who are either male or female. Females of childbearing potential must be
using a medically approved method of birth control and must agree to continue to use
birth control throughout the study, or must be surgically sterilized (tubal ligation,
hysterectomy) or post-menopausal for at least 1 year.

3. Condition

1. Subjects who have a baseline ejection fraction greater than or equal to 25% and
less than or equal to 45% by echocardiography determined by the echocardiography
core laboratory.

2. Subjects who have been treated for heart failure for at least 90 days (including
treatment with a β-blocker for at least 90 days unless the subject is intolerant)
and are in New York Heart Association functional Class III and IV at the time of
enrollment.

3. Subjects receiving appropriate, stable medical therapy during the 30 days prior
to enrollment for treatment of heart failure according to the region- specific
guideline recommendations. For patients with EF≤35%, this regimen shall consist
of the appropriate doses of diuretics, ACE-inhibitor or angiotensin II receptor
blocker and β-blocker. Stable is defined as no more than a 100% increase or 50%
decrease in dose.

4. Subjects who, in the opinion of the Principal Investigator (based on the current
guidelines for clinical practice ), have a clinical indication for an implanted
cardiac defibrillator (ICD, e.g., EF≤35%) and/or pacemaker, must have an existing
device or agree to undergo implantation of such a device unless the patient
refuses to undergo the implantation of such device for personal reasons.

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

Exclusion Criteria:

1. Subjects whose baseline peak VO2 is <9 or >20 ml O2/min/kg.

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

3. Subjects who have clinically significant angina pectoris, consisting of angina during
daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an
episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes
during exercise testing performed during baseline evaluation.

4. Subjects who have been hospitalized for heart failure which required the use of
inotropic support within 30 days of enrollment.

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

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

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

8. Subjects whose exercise tolerance is limited by a condition other than heart failure
(e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic
conditions) or who are unable to perform baseline stress testing.

9. 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.

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

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

12. Subjects who have mechanical tricuspid valve.

13. Subjects who have a prior heart transplant.

14. Subjects on dialysis.

15. Subjects who are participating in another experimental protocol.

16. Subjects who are unable to provide informed consent.