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

Completed · Not applicable

Conditions studied: Heart Failure

In brief

This study is a feasibility study of the HeartPOD™ Heart Failure Management System with DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure. The device being studied in this trial monitors heart function and alerts the patient and physician of necessary changes to medication. The study will assess the safety, reliability, and preliminary efficacy of the HeartPOD™ system.

Key facts

Study ID

NCT00547729

Run by

Abbott Medical Devices

People needed

71

Starts

2005-03-01

Expected to finish

2008-06-01

Last updated by the study team

2021-09-02

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Scripps Green Hospital — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• The Ohio State University — Columbus, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• Alfred Hospital — Melbourne, Victoria, Australia
• University of Auckland — Auckland, New Zealand
• Christchurch Hospital — Christchurch, New Zealand

Full record on ClinicalTrials.gov

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