Australian medical technology company QHeart Medical has received conditional Human Research Ethics Committee approval to begin a world-first human study of its pumpless heart failure therapy device.
The clinical-stage Brisbane-based company plans to commence the pilot study in early 2026 at Monash Health’s Victorian Heart Hospital. The trial will evaluate QHeart’s TARR™ device in patients with acute decompensated heart failure, a sudden and life-threatening worsening of heart failure that currently has limited effective treatment options.
Heart failure remains one of the most common causes of hospital admission in Australia, with around 170 people hospitalised each day — roughly one person every nine minutes. According to data published in the Medical Journal of Australia, nearly one in four patients hospitalised with heart failure are re-admitted within 30 days of discharge.
Between 2013 and 2017, unplanned re-admissions related to heart failure cost the Australian health system an estimated $604 million. Persistent congestion and kidney-related complications are among the leading causes of repeat admissions and poor patient outcomes.
QHeart’s TARR™ device is designed to support the heart to pump more effectively during the critical hospitalisation period, with the aim of reducing congestion and improving patient outcomes.
“The key innovation in our device is its pumpless, passive recoil design what we call Aortic Recoil Repair (ARR) technology,” said QHeart chief executive and chief technology officer Dr Peter Walsh.
“Rather than pumping for the heart, it supports the heart to pump more effectively itself.
“There is no external power source. It is powered entirely by the patient’s own body,” he said.
“We believe the TARR™ therapy could provide clinicians with a lower-risk, earlier intervention for the fifty per cent of patients who currently have no effective treatment options.”
The approval follows a multi-year pre-clinical and clinical development program, including studies in an induced pig model of heart failure that demonstrated improvements in cardiac output and stroke volume.
Senior cardiothoracic surgeon at Monash Health, Professor Julian Smith, said earlier surgical studies were critical in establishing the foundation for the upcoming human trial.
“In clinical studies using a surgical version of QHeart’s Aortic Recoil Repair (ARR) therapy, we found clinically significant improvements in heart output in scheduled heart surgery patients,” Professor Smith said.
“The new TARR™ device has performed equally well in pre-clinical studies.”
Head of interventional cardiology at Monash Health and co-principal investigator on the trial, Associate Professor Robert Gooley, said the therapy addressed a particularly challenging aspect of acute heart failure care.
“Patients with acute heart failure are known to also have kidney dysfunction, which causes further congestion and worsening of heart output. This leads to reduced quality of life and higher patient mortality,” he said.
“If we can show the TARR to improve patients’ heart output and reduce their congestion, with low risk and blood friendly use, the potential of the TARR therapy is likely to be transformative for in-hospital acute heart failure treatment.”
Following the pilot study, QHeart Medical plans to progress the device through a staged clinical and regulatory pathway, including multi-site trials and FDA clearance. The clinical program has been supported by Australian Government CRC Projects funding, with the company now preparing a capital raise to fund further trials through to commercialisation.
If you want, I can also tighten either story for print space, or rework the intros to be more trade- or health-sector focused.
