Condition: PFO · PFO - Patent Foramen Ovale · Cryptogenic Stroke · Sponsor: Recross Cardio, Inc.
The goal of this clinical trial is to test a new heart device called P3 Occluder System in patients who have a small opening between the upper chambers of the heart (called a Patent Foramen Ovale or PFO) and have experienced a stroke that may be related to this heart opening. The main question it aims to answer is: • Is the P3 Occluder System safe and effective for closing a PFO in patients who have had a stroke that could be related to a PFO. Participants will: * Undergo the procedure to implant the P3 Occluder System, if deemed appropriate. * Visit their doctor at 1 month, 3 months, 6 months, 1 year and 5 years after the procedure for follow up exams. * Answer a phone call from study staff at 2 years, 3 years and 4 years after the procedure to answer a survey.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| UCLA | Los Angeles, California, United States | Recruiting |
| The Cardiac and Vascular Institute | Gainsville, Florida, United States | Recruiting |
| Tufts Medical Center | Boston, Massachusetts, United States | Recruiting |
| Columbia University Medical Center/ NewYork Presbyterian Hospital | New York, New York, United States | Recruiting |
| Prisma Health - Upstate | Greenville, South Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07172464