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

August 9, 2021 updated by: Abbott Medical Devices

Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
  • New Zealand
      • Auckland, New Zealand
        • University of Auckland
      • Christchurch, New Zealand
        • Christchurch Hospital
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Green Hospital
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HeartPOD™ System
Implantation of HeartPOD™ Heart Failure Management System with DynamicRx®
Device: HeartPOD™ System
HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: William T. Abraham, MD, FACC, Ohio State University
  • Principal Investigator: Henry Krum, MD, Monash University/Alfred Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-05-04/HP-12-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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