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

NCT00547729 | Completed Results DMC FDA Device

• 1 other identifier: HP-05-04/HP-12-04
• Study Type: interventional
• Target: 71
• Locations: 3 countries
• Sites: 7

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.

Conditions

Heart Failure

Keywords

Heart Failure; Left Atrial Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.

  Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.

  6 Weeks

Study Arms (1)

HeartPOD™ System

EXPERIMENTAL

Implantation of HeartPOD™ Heart Failure Management System with DynamicRx®

Device: HeartPOD™ System

Interventions

HeartPOD™ System DEVICE

HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.

HeartPOD™ System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (7)

Scripps Green Hospital

La Jolla, California, 92037, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

University of Auckland

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Related Publications (4)

• 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.

  PMID: 18056531 BACKGROUND

• 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.

  PMID: 23448187 DERIVED

• 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.

  PMID: 21920328 DERIVED

• 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.

  PMID: 20176990 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clay Cohorn - Director, Clinical Research
• Organization: Abbott

clay.cohorn@abbott.com

469-929-7116

Study Officials

• William T. Abraham, MD, FACC

  Ohio State University

  STUDY CHAIR

• Henry Krum, MD

  Monash University/Alfred Hosptial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 23, 2007
• Study Start: March 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 2, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (4); NZ (2)