Tufts Medical Center is the first activated site for the PROTEA-PFO Early Feasibility Study, investigating innovative approaches to patent foramen ovale (PFO) closure in patients at risk for stroke.
A PFO is a small opening between the heart’s upper chambers that usually closes shortly after birth. While roughly one in four adults has a PFO, most never experience complications. In certain cases, however, a clot can pass through the opening and travel to the brain, potentially causing a stroke.
On November 28, Tufts Medical Center successfully performed the first implant of the study device in a human, the P3 Occluder System. The trial will evaluate the device in patients who have experienced a stroke that is likely to be related to a PFO. This national study aims to gather early data on safety and feasibility to inform future strategies for stroke prevention.
The study is co-led by Carey Kimmelstiel, MD, Director of the Interventional Cardiology Center at Tufts Medical Center and Professor at Tufts University School of Medicine, and Neurology Chairman Emeritus, David Thaler, MD, PhD, Professor at Tufts University School of Medicine.
- Dr. Kimmelstiel has been instrumental in developing PFO closure techniques and advancing clinical understanding of the procedure.
- Dr. Thaler, co-developer of the RoPE Score, has contributed extensively to research evaluating the relationship between PFO and stroke.
As the first activated site, Tufts Medical Center is contributing critical research, shaping future approaches to stroke prevention and improving outcomes for patients with PFO.
