Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a N
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: • I
| Condition(s) | PFO, PFO - Patent Foramen Ovale, Cryptogenic Stroke, Patent Foramen Ovale, PFO-associated Stroke |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Patient must be ≥ 18 and ≤ 65 years of age 2. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release. 3. Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct. 4. Modified Rankin score (mRS) ≤ 3. 5. Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee. 6. Patient is willing and capable of providing informed consent. 7. Prior to index procedure (7-day window), persons of childbearing potential must have a n |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Recross Cardio, Inc. |
| Locations | Los Angeles, California, United States; Gainesville, Florida, United States; Boston, Massachusetts, United States; New York, New York, United States; Greenville, South Carolina, United States |
| Start date | 2025-10-09 |
| NCT ID | NCT07172464 |
| Official listing | https://clinicaltrials.gov/study/NCT07172464 |