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

Inclusion Criteria

• Age > 18 and 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 ( 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 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.