Royal Sussex County Hospital, Brighton, UK, has enrolled the first patient in the United Kingdom for the Gore REDUCE clinical study of patent foramen ovale closure. David Hildick-Smith, director of Cardiac Research Unit, Brighton and Sussex University Hospitals and study investigator, performed the first procedure.
REDUCE is an FDA approved prospective, randomised, multicentre, international trial designed to demonstrate the safety and effectiveness of the Gore Helex Septal Occluder for patent foramen ovale closure in patients with a history of cryptogenic stroke or imaging-confirmed transient ischaemic attack. The unique study includes up to 50 investigational sites in the US and Europe.
“Royal Sussex County Hospital is honored to take part in this international trial with the hope of advancing treatment options for patients suffering from a history of cryptogenic strokes,” said Hildick-Smith.
Patients are randomised to one of two treatment arms, either anti-platelet medical management alone or device closure of the patent foramen ovale in conjunction with anti-platelet medical management. The primary endpoint is freedom from recurrent ischaemic stroke, imaging confirmed transient ischaemic attack, or death due to stroke through 24 months post-randomisation.
The Gore Helex Septal Occluder is composed of ePTFE material supported by a single wire nitinol frame. Over the course of several weeks to months following implantation of the device, cells begin to infiltrate and grow over the ePTFE material, aiding in the successful closure of the defect.
The US Food and Drug Administration (FDA) approved the Gore Helex Septal Occluder for treatment of atrial septal defect in 2006. The device received CE mark for atrial septal and patent foramen ovale closure in 1999. Participation in the Gore REDUCE clinical study by centres in the UK and Nordic countries is helping to drive enrolment in this pivotal trial.
“We are committed to reducing incidences of stroke. The enrolment of the first UK patient in the Gore REDUCE clinical study is a step in the right direction,” said Stuart Broyles, associate with the Gore Medical Division Stroke Business. “Due to our European experience regarding the clinical performance of the Gore Helex Septal Occluder and our unique study design, we are confident in the completion of this study and the pursuit of an FDA indication for patent foramen ovale closure and the prevention of recurrent stroke.”