What this Trial Is About

Researchers are evaluating a new method called the Swartz sheath with angioplasty guidewire-assisted technique for closing a patent foramen ovale (PFO), a heart condition where an opening between the heart's upper chambers fails to close properly. This trial focuses on patients aged 18 to 65 who have a history of unexplained stroke or transient ischemic attack and require PFO closure according to current guidelines. The goal is to compare the effectiveness and safety of this new technique against the conventional method in helping guide instruments through the PFO tunnel during closure procedures. Participants are randomly assigned to one of two groups: one group receives the PFO closure using the Swartz sheath combined with an angioplasty guidewire, while the other group undergoes the procedure using a conventional multi-functional catheter technique guided by imaging tools. The new technique involves carefully advancing guidewires and sheaths through the PFO tunnel to aid device placement. The study records details like procedure time, contrast use, and any serious complications. During the study, patients have follow-up visits at 1, 3, 6, and 12 months after the device is implanted. At these visits, doctors check for any remaining leaks through the PFO, device movement or embolization, and overall safety. The main outcome measured is the time taken for the guidewire to pass through the PFO tunnel during the procedure. This comprehensive monitoring helps determine the potential benefits and risks of the new closure technique over a year-long period.

Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)