Aventura Hospital and Medical Center is proud to announce its participation in the Gore “REDUCE” Clinical Study for the closure of PFO defects in patients with stroke. The study will determine whether PFO closure is as effective as or better than standard medical therapy in preventing a recurrent stroke.
“PFO is a small hole in the heart that a person is born with, which is pretty common,” said Principal Investigator Roberto Cubeddu, MD, Medical Director of Structural Heart Disease at Aventura Hospital and Medical Center. “For patients with an unknown cause for their recurrent strokes, PFO may be directly related.”
In fetuses, the patent foramen ovale (PFO) allows circulation to occur as the lungs develop. After birth the opening usually closes, but in approximately 20 to 25 percent of adults the hole does not close. If the opening is present in adults, blood clots can potentially travel through this hole to the brain and cause strokes.
The study will randomize patients with prior history of stroke and PFO into two groups who will receive varying anti-stroke therapies. One test group will undergo PFO closure using the GORE HELEX Septal Occluder, while the other will receive antiplatelet medical management such as aspirin and Plavix.
An interdisciplinary effort, Dr. Cubeddu will be assisted by Co- Investigator Jonathan Cross, MD, Director of Stroke. “This trial will precisely answer whether or not closing a PFO defect will reduce the risk for subsequent stroke,” said Dr. Cross.
“Aventura Hospital and Medical Center is always looking for ways to stay at the forefront of care by participating in groundbreaking clinical studies such as this one,” said Heather Rohan, CEO of Aventura Hospital and Medical Center. “I congratulate Dr. Robert Cubeddu and our excellent research team for spearheading this clinical trial to improve our quality of care.”
If you know a patient between the ages of 18 and 59 who has been diagnosed with an ischemic stroke or suffer from recurrent strokes, think they may have PFO and would be willing to participate in this study please call Joseph McConnell, Clinical Research Coordinator at 305-682-7322.
For more information on the live-saving programs at Aventura Hospital and Medical Center, visit AventuraHospital.com or call 305-682- 7000.