Clinical trial NCT00547729: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)
Official title: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Left Atrial Pressure Monitoring
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Direct cardiac measurements may provide an accurate, reliable and medically acceptable way of informing patients and physicians of worsening CHF prior to the development of symptoms. This may enable physicians to take preventative measures and avoid hospitalization.

This is a feasibility study to assess the safety, reliability, and preliminary efficacy of the HeartPOD™ Heart Failure Management System with DynamicRx®. This feasibility study will be performed in two phases. The first phase will enroll 20 patients at sites in Australia and New Zealand and the second phase will enroll 20 patients at sites in the U.S.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
timeFrame: 6 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: University of Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Ohio State University
name: William T. Abraham, MD, FACC
role: STUDY_CHAIR
affiliation: Monash University/Alfred Hosptial
name: Henry Krum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritzema J, Melton IC, Richards AM, Crozier IG, Frampton C, Doughty RN, Whiting J, Kar S, Eigler N, Krum H, Abraham WT, Troughton RW. Direct left atrial pressure monitoring in ambulatory heart failure patients: initial experience with a new permanent implantable device. Circulation. 2007 Dec 18;116(25):2952-9. doi: 10.1161/CIRCULATIONAHA.107.702191. Epub 2007 Dec 3.
citation: Pretorius V, Birgersdotter-Green U, Heywood JT, Hafelfinger W, Gutfinger DE, Eigler NL, Love CJ, Abraham WT. An implantable left atrial pressure sensor lead designed for percutaneous extraction using standard techniques. Pacing Clin Electrophysiol. 2013 May;36(5):570-7. doi: 10.1111/pace.12111. Epub 2013 Feb 28.
citation: Ritzema JL, Richards AM, Crozier IG, Frampton CF, Melton IC, Doughty RN, Stewart JT, Eigler N, Whiting J, Abraham WT, Troughton RW. Serial Doppler echocardiography and tissue Doppler imaging in the detection of elevated directly measured left atrial pressure in ambulant subjects with chronic heart failure. JACC Cardiovasc Imaging. 2011 Sep;4(9):927-34. doi: 10.1016/j.jcmg.2011.07.004.
citation: Ritzema J, Troughton R, Melton I, Crozier I, Doughty R, Krum H, Walton A, Adamson P, Kar S, Shah PK, Richards M, Eigler NL, Whiting JS, Haas GJ, Heywood JT, Frampton CM, Abraham WT; Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) Study Group. Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure. Circulation. 2010 Mar 9;121(9):1086-95. doi: 10.1161/CIRCULATIONAHA.108.800490. Epub 2010 Feb 22.