Door opens for Ventracor clinical trials

Ventracor has gained approval from the Alfred Hospital's Ethics Committee, paving the way for the first clinical trial of its VentrAssist artificial heart device to begin.

The approval is subject to some minor amendments to the trial protocol, which Ventracor CEO Michael Spooner said he expected would be resolved soon.

He said clinical investigator Prof Don Esmore, who leads the heart and lung transplant team at the Alfred Hospital in Melbourne, would be responsible for the trial with the company playing a support role throughout.

The trial, which will test safety and efficacy of the left ventricular assist device (LVAD) on a group of 10 patients with end-stage congestive heart failure, is expected to begin toward the end of the first quarter this year. The device will be implanted in an operation lasting three to four hours, and then after a short stay in hospital and at the discretion of the clinical team, the patient would be discharged, according to Spooner.

Spooner said the trial should progress rapidly once patients were recruited. "We would hope that [the trial] would be undertaken fairly quickly... to help those people recover their quality of life," he said.

He explained that the device was not intended to be just a stop-gap measure while waiting for a heart transplant, but a long-term alternative that would not require anti-rejection medication. The device is unique among LVADs as it has only one moving part and is designed to not wear out.

The potential market for the VentrAssist device is enormous, with 800,000 patients with end-stage congestive heart failure annually, and only 3500 hearts available for transplant.

The initial trial will be followed in the second half of the year by a global pivotal trial to be performed in leading hospitals in Australia, Europe and the US, testing the device on 55-60 patients and comparing the results to a cohort of 50 patients receiving the best current available treatments.

Spooner said that Ventracor was in discussions with a number of major hospitals in Europe and the USA, and hoped to recruit about 20 centres for the trial.

He noted that the company would seek European CE Mark approval before applying to the US FDA, because of differences between the European and US regulatory systems.