NCT07172464 Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
| NCT ID | NCT07172464 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Recross Cardio, Inc. |
| Condition | PFO |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-10-09 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-10-09 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 negative pregnancy test. Exclusion Criteria: 1. Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding \>4 mm into the lumen), large artery atherosclerotic di
Frequently Asked Questions
Who can join the NCT07172464 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying PFO. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07172464 currently recruiting?
Yes, NCT07172464 is actively recruiting participants. Visit ClinicalTrials.gov or contact Recross Cardio, Inc. to inquire about joining.
Where is the NCT07172464 trial being conducted?
This trial is being conducted at Los Angeles, United States, Gainesville, United States, Boston, United States, New York, United States and 1 additional location.
Who is sponsoring the NCT07172464 clinical trial?
NCT07172464 is sponsored by Recross Cardio, Inc.. The trial plans to enroll 15 participants.