Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000531415
Ethics application status
Approved
Date submitted
17/10/2007
Date registered
17/10/2007
Date last updated
17/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial investigating the HeartPOD, a new heart pressure monitoring device, to optimise treatment in patients with severe heart failure
Scientific title
A trial investigating the safety and effectiveness of the HeartPOD as a hemodynamically guided home self-therapy in severe heart failure patients
Universal Trial Number (UTN)
Trial acronym
HOMEOSTASIS 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 2469 0
Condition category
Condition code
Cardiovascular 2570 2570 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial aims to test the safety and efficacy of a new pressure recording device (the HeartPOD). Once a subject has fulfilled the inclusion and exclusion criteria and signed a consent form, the device would be permanently implanted in the wall of the left atrium to continuously monitor left atrial pressure. The pressure readings are viewed on a hand held computer (PDA) which receives the information by wireless transmission through the skin.

The device is implanted and monitored for 12 months. The first 6 weeks will be used to assess the safety of the device. For the first three months the participants medication will only be altered based on symptoms, but pressure recordings will be taken to correlate pressures with symptoms. For months four to six medication will be adjusted based on symptoms and left atrial pressure. At months seven to twelve medication will be managed by the participant based on the pressure reading and instructions given by the PDA.
Intervention code [1] 2198 0
Treatment: Devices
Comparator / control treatment
Usual Clinical Care entailing drug dose adjustments by a cardiologist and/or family doctor based on clinical signs and symptoms.
Control group
Active

Outcomes
Primary outcome [1] 3475 0
The HeartPOD is safe and reliably measures left atrial pressure in patients with severe heart failure.
Timepoint [1] 3475 0
6 weeks
Secondary outcome [1] 5797 0
The Heart POD is effective in guiding titration of heart failure treatment
Timepoint [1] 5797 0
12 months

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.
American Heart Association(AHA)/American College of Cardiology(ACC) Stage C heart failure with New York Heart Association (NYHA) Class III or IV symptoms.
Baseline 6-minute walk distance <450 meters (1476 feet)
Minimum of one (1) prior hospital admission within the last 12 months for exacerbation of Congestive Heart Failure (CHF).
Female subjects of child-bearing 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.
The subject or the subject’s legal representative has been informed of the nature of the study and agrees to it’s provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intractable Heart Failure (HF) with resting symptoms despite maximal medical therapy (AHA/ACC Stage D) or active listing for cardiac transplantation.( 6 months survival expected)
Resting systolic blood pressure <90 or > 180 mm Hg.
Acute Myocardial Infarction (MI), unstable ischemic syndrome within the last 6 weeks.
Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within +/- six weeks.
Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or >moderate or large small pericardial effusion.
Surgical correction of congenital heart disease involving atrial septum
Cerebrovascular Accident (CVA) or Transient Ischaemic Attack (TIA) within 6 months. History of uncorrected cerebral vascular disease
Atrial thrombus or myxoma
Chronic atrial fibrillation
Symptomatic bradyarrhythmia or sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) unless successfully treated with cardiac rhythm management device for >6 weeks.
Atrial septal thickness > 5 mm.
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 anti-platelet medications.
Creatinine >2.5 gm/dl (220umol/L).
Temperature >37.8 ?C 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 clinically interferes with the current study endpoints.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Non blinded study
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 625 0
New Zealand
State/province [1] 625 0

Funding & Sponsors
Funding source category [1] 2713 0
Commercial sector/Industry
Name [1] 2713 0
St Jude Medical
Country [1] 2713 0
United States of America
Funding source category [2] 2714 0
Commercial sector/Industry
Name [2] 2714 0
St Jude Medical
Country [2] 2714 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
St Jude Medical
Address
St. Jude Medical World Headquarters
One Lillehei Plaza
St Paul MN 55117-9913
USA
Country
United States of America
Secondary sponsor category [1] 2458 0
None
Name [1] 2458 0
Address [1] 2458 0
Country [1] 2458 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4634 0
Multi-region Ethics Committee
Ethics committee address [1] 4634 0
PO Box 5013
Wellington
Ethics committee country [1] 4634 0
New Zealand
Date submitted for ethics approval [1] 4634 0
01/10/2004
Approval date [1] 4634 0
Ethics approval number [1] 4634 0
CTB/04/08/131

Summary
Brief summary
Despite improvements in treatment of heart failure over the last three decades it still carries a higher mortality rate than most cancers and is the most common reason for hospitalising people over the age of 65. Current treatment for heart failure is medication, adjusted based on the person's symptoms and / or weight gain. Adjustment of drug therapy can prevent rapid deterioration and the need for hospitalisation.

Studies with cardiac catheterisation have demonstrated that one of the best predictors of the severity of heart failure and its response to treatment is raised left atrial pressure which often occurs several hours to several days before the onset of symptoms. Left atrial pressure cannot be accurately estimated from clinical assessment, and currently can only be estimated infrequently at single time points by invasive catheterisation of the right heart.

This trial aims to test the safety and efficacy of a new pressure recording device (the HeartPOD). This device would be permanently implanted in the wall of the left atrium, to continuously monitor left atrial pressure. The pressure readings are viewed on a small ‘personal digital assistant (PDA)’ (hand held computer) which receives the information from the device by wireless transmission through the skin.

Th trial will enrol 20 participants who will have the device implanted and monitored for 12 months. The first 6 weeks will be used to assess the safety of the device. For the first three months the participants medication will be altered based on symptoms, but pressure recordings will be taken to correlate pressures with symptoms. For months four to six medication will be adjusted based on symptoms and left atrial pressure. At months seven to twelve medication will be managed by the participant based on the pressure reading and instructions given by the PDA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28123 0
Address 28123 0
Country 28123 0
Phone 28123 0
Fax 28123 0
Email 28123 0
Contact person for public queries
Name 11280 0
Assoc. Professor Richard Troughton
Address 11280 0
Department of Medicine
University of Otago
Christchurch School of Medicine
PO Box 4345
Christchurch 8140
Country 11280 0
New Zealand
Phone 11280 0
+64 3 3640826
Fax 11280 0
+64 3 3641115
Email 11280 0
[email protected]
Contact person for scientific queries
Name 2208 0
Assoc. Professor Richard Troughton
Address 2208 0
Department of Medicine
University of Otago
Christchurch School of Medicine
PO Box 4345
Christchurch 8140
Country 2208 0
New Zealand
Phone 2208 0
+64 3 3640826
Fax 2208 0
+64 3 3641115
Email 2208 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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