World first trial to test human implant of HeartPOD™

November 30, 2005

Researchers at The Alfred and Monash University are leading a world first trial to investigate whether the implantation of a specially designed HeartPODTM monitoring system in heart failure patients can keep them out of hospital and lead to a better quality of life.

The study, known as the HOMEOSTASIS study, aims to evaluate the safety and performance of the HeartPODTM system, which is designed to monitor and detect worsening congestive heart failure before the onset of symptoms and provide early preventative treatment, thus avoiding emergency hospitalisation.

For the first time ever, the system enables heart failure patients to personally monitor their condition and adjust their medication themselves without having to visit a doctor each time.

It is comprised of a permanently implanted sensor system that is designed to measure the pressure in the left atrium, the core body temperature and the electrical conduction of the heart. It is implanted in the patients' left atrial chamber by a cardiac catheterization procedure.

The sensor system sends information about the way the heart is working by wireless transmission to a handheld computer, which then analyses the signals and tells the patient what medications to take and when to take them.

This is a world first study of the HeartPODTM device being implanted into people, with 16 implants including four at The Alfred already completed. The trial will involve a minimum of 20 patients from four investigation sites across Australia and New Zealand.

Principal researcher and Head of Clinical Pharmacology at The Alfred and Monash University, Professor Henry Krum, said that the current treatment for congestive heart failure patients involved having to wait until the patient presented with symptoms that their condition was deteriorating and by that stage, the patient had usually been admitted to hospital.

"Unfortunately, we currently need to wait until the patient has respiratory distress or breathlessness, reduced exercise capacity, swelling of the ankles, fatigue or weakness before we can adjust their medications," said Professor Krum.

"Often by the time symptoms occur it is too late and the patient is in a situation where they require emergency hospitalisation to control their condition."

Co-principal investigator Dr Tony Walton, who performs the implants, said direct measurements from the heart by the HeartPODTM system may provide an accurate, reliable and medically acceptable way of telling the patient that the congestive heart failure is worsening, often hours to days before the symptoms would develop.

"This will then enable the patients to take preventative measures and avoid hospitalisation," he said.

People involved in the study have congested heart failure - a condition in which the heart's ability to pump properly is reduced. Congestive heart failure is usually a chronic disease, which means that it's a long-term condition that tends to become gradually worse.
Patients with congestive heart failure who have advanced disease and have been hospitalized for it in the last year who are interested in taking part in the trial should contact Jane Brack on 61-39-207-1931.

HeartPOD TM, developed and manufactured by Savacor, is a precision scientific instrument designed to withstand the rigors of up to decades of operation from within the human heart. It is not based on the consumer electronics product iPOD.

Interview opportunities:For more information phone The Alfred Public Affairs on 61-39-276-2266 or Monash University on 61-39-905-9315

Research Australia

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