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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00547729




Registration number
NCT00547729
Ethics application status
Date submitted
19/10/2007
Date registered
23/10/2007

Titles & IDs
Public title
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)
Scientific title
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.
Secondary ID [1] 0 0
HP-05-04/HP-12-04
Universal Trial Number (UTN)
Trial acronym
HOMEOSTASIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HeartPOD™ System

Experimental: HeartPOD™ System - Implantation of HeartPOD™ Heart Failure Management System with DynamicRx®


Treatment: Devices: HeartPOD™ System
HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
Timepoint [1] 0 0
6 Weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
United States of America
State/province [3] 0 0
Oklahoma
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William T. Abraham, MD, FACC
Address 0 0
Ohio State University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00547729