Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)

The Sponsor believes that direct measurements from your heart may provide an accurate,
reliable and medically acceptable way of telling you and your doctor that your CHF is
worsening hours to days before the above symptoms would develop and you would notice. This
may enable you and your doctor to take preventative measures and avoid hospitalization.

Inclusion Criteria:

- Age > 18 and < 85.

- Documented history of congestive heart failure resulting from ischemic or non-ischemic
cardiomyopathy with systolic or diastolic dysfunction of at least 6 months duration.

- Patients with LVEF < 40% should receive maximally tolerated doses of ACE-I (or ARB if
ACE-I is not tolerated), beta blockers, and anti-aldosterone therapy. The combination
of hydralazine and nitrates should be considered in the persistently symptomatic
African American patient.

- A history of NYHA Class II (OUS only), III or IV symptoms.

- Minimum of one (1) prior hospital admission within the last 12 months for exacerbation
of CHF or one (1) presentation to the Emergency Department or Clinic requiring
parenteral diuretic, vasodilator, inotrope, nesiritide, or equivalent treatment.

- Female subjects of childbearing potential must have a negative pregnancy test within
seven (7) days before the procedure.

- Central venous vascular access.

- Capable of Valsalva maneuver with airway pressure > 40 mm Hg for 10 seconds.

- The subject and the treating physician agree that the subject will comply with all
required post-procedure follow-up, and that the patient is capable of correct device
use as outlined in the protocol.

- Written informed consent.

Exclusion Criteria:

- Intractable HF with resting symptoms despite maximal medical therapy or active listing
for cardiac transplantation (< 6 months survival expected).

- Resting systolic blood pressure < 90 or > 180 mmHg.

- Acute MI, unstable ischemic syndrome within the last 6 weeks.

- Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned
within 6 weeks.

- Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy,
amyloidosis or other infiltrative heart disease, constrictive, restrictive disease,
tamponade, or moderate or large pericardial effusion.

- Subject has a history of deep venous thrombosis or pulmonary embolism.

- Surgical correction of congenital heart disease involving atrial septum.

- CVA or TIA within 6 months. History of uncorrected cerebral vascular disease.

- Atrial or ventricular thrombus, tumor or systemic thromboembolism.

- Chronic atrial fibrillation.

- Symptomatic bradyarrhythmia or sustained VT/VF unless successfully treated with
cardiac rhythm management device for 6 weeks.

- Atrial septal defect or patent foramen ovale > 2 mm in diameter.

- Life expectancy < 1 year from malignancy, primary pulmonary hypertension, renal,
hepatic, or neurological condition, etc.

- Gastrointestinal bleeding during the last 6 months.

- Coagulopathy or uninterruptible anticoagulation therapy or unable to take antiplatelet
medications.

- Creatinine > 2.5 gm/dl

- Temperature > 37.8C or white blood cell count (WBC) > 13,000/mm3.

- The subject is currently participating in an investigational drug or another device
study that has not completed the primary endpoint or that clinically interferes with
the current study endpoints.