P3 Occluder for Patent Foramen Ovale

(PROTEA-PFO Trial)

This trial tests a new heart device called the P3 Occluder System to determine if it can safely and effectively close a small opening in the heart, known as a Patent Foramen Ovale (PFO), in individuals who have had a stroke possibly linked to this opening. The goal is to prevent future strokes related to PFO. Participants will have the P3 Occluder System implanted and will attend follow-up visits and calls over the next few years. This trial is suitable for adults diagnosed with a PFO who have experienced a stroke that doctors believe might be connected to the heart opening. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to new treatment options for stroke prevention.

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are unable to discontinue anticoagulation (blood-thinning) medications for reasons other than the stroke related to the trial.

Research has shown that using devices to close a patent foramen ovale (PFO), a small opening in the heart, is generally safe. Studies have found that this procedure usually carries a low risk of complications. For instance, one study reported few problems during and after PFO closure, indicating minimal risk of negative effects.

The Recross P3 Occluder (P3O) System is unique because it offers a new approach to closing a patent foramen ovale (PFO), which is a small hole in the heart that didn't close the way it should after birth. Unlike standard treatments that might involve surgical intervention, the P3O System is a transcatheter device, meaning it can be implanted without open-heart surgery. This minimally invasive delivery method potentially reduces recovery time and lowers the risk of complications. Researchers are excited about this treatment because it could reduce the risk of recurrent strokes in patients with PFO-associated strokes more effectively and safely than current options.

Research has shown that closing a patent foramen ovale (PFO), a small opening in the heart, can lower the risk of strokes in some patients. In this trial, participants will receive the Recross P3 Occluder (P3O) System, developed for transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke. Studies have found that devices like the Recross P3 Occluder effectively serve this purpose. For instance, the Amplatzer PFO Occluder, a similar device, proved safe and effective in preventing repeat strokes over the long term. Research on various PFO closure devices indicates that many patients experienced successful closure and fewer strokes afterward. This suggests that devices like the P3 Occluder could be promising in preventing strokes by closing the PFO.¹⁴⁵⁶⁷