Greenslopes involved in Australian-first clinical trial to reduce stroke
Jan 13, 2020
Greenslopes Private Hospital is part of a new international clinical trial exploring the potential benefits of an implantable device for reducing stroke in eligible heart patients.
The OPTION clinical trial is designed to explore if an implantable device - called the WATCHMAN FLX – is a reasonable alternative to blood thinners when it comes to closing the left atrial appendage of the heart. This trial relates specifically to cardiac patients with non-valvular atrial fibrillation who undergo an ablation procedure.
Atrial fibrillation is an abnormal heart rhythm which causes the upper chambers of the heart to quiver, leading to poor blood flow, shortness of breath and fatigue. An ablation can help decrease this burden through scarring the tissue around the veins in the upper left heart chamber. However, there is still a risk of stroke following an ablation.
One option to address the need for stroke reduction in atrial fibrillation patients is blood thinners. The second option is the insertion of left atrial appendage closure implants such as the WATCHMAN.
Greenslopes Private Hospital cardiologist and cardiac electrophysiologist, Dr Karen Phillips, explained the device is essentially “a tiny plug that sits inside the heart that seals off where the blood clots potentially form.”
The implantation of this device is designed to prevent harmful blood clots from escaping, travelling through an artery to the brain and causing a stroke.
In Australia, the main treatment option for patients with the heart rhythm condition has been long-term, daily use of blood thinning medication; the WATCHMAN FLX device is currently only available to patients who cannot take the medication.
“The blood thinning treatment is life-long; unfortunately the risk of bleeding gets higher as the patients age,” Dr Phillips said.
Approximately two per cent of patients who take blood thinners will have significant bleeding complications each year.
The OPTION trial will allow specialists to fit a newly developed model of the WATCHMAN FLX in patients undergoing an ablation procedure.
“At the moment the treatment is reactive - you wait until someone bleeds from the blood thinning medication before offering the alternative treatment. This trial gives us an opportunity to perform both procedures at once,” Dr Phillips said.
Greenslopes is one of only two Australian hospitals participating in the global trial, which is expected to recruit 1600 patients.
Half will be asked to take blood thinners, while the other half will receive a WATCHMAN FLX implant.
“We’re the first in the southern hemisphere using this particular atrial fibrillation device, which is a big feather in our cap,” Dr Phillips said.
The hospital has started to enrol patients in the trial, which will run over 18 months.
Dr Karen Phillips (Cardiologist) with theatre staff at Greenslopes Private Hospital. L-R: Rebecca Sanchez, Jennifer Taylor, Sapphire Kubala, Alex Wellstead, Dr Karen Phillips, Darren Pullman and Dr Terri Hall.