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NCT07172464 · ClinicalTrials.gov registry record · NA
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
A NA study of Patent Foramen Ovale and PFO - Patent Foramen Ovale, sponsored by Recross Cardio.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 5
- Study locations
NCT07172464: Recruiting NA study of Patent Foramen Ovale and PFO - Patent Foramen Ovale, sponsored by Recross Cardio.
NCT07172464 is a NA study of Patent Foramen Ovale and PFO - Patent Foramen Ovale that is actively recruiting participants, run by Recross Cardio. The registered enrollment target is 15 participants, below the 419-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07172464, a NA study of Patent Foramen Ovale and PFO - Patent Foramen Ovale, is actively recruiting participants, sponsored by Recross Cardio.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Rate of Major Adverse Cardiovascular Events (MACE) at 30 days post-procedure, defined as the composite of cardiac death (CD), myocardial infarction (MI), and stroke events.
Conditions Studied
Interventions
- DEVICE Recross P3 Occluder (P3O) System
Study Locations (5)
California
- UCLA - Los Angeles
Florida
- The Cardiac and Vascular Institute - Gainesville
Massachusetts
- Tufts Medical Center - Boston
New York
- Columbia University Medical Center/ NewYork Presbyterian Hospital - New York
South Carolina
- Prisma Health - Upstate - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-10-09 |
| Est. Completion | 2031-02 |
| Phase | NA |
What NCT07172464 shows while recruiting
NCT07172464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 419-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (96% lower).
The record links to 5 conditions, with Patent Foramen Ovale appearing as the primary indexed condition, and to 1 intervention - of which Recross P3 Occluder (P3O) System is the first listed.
NCT07172464 lists 5 locations in 5 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT07172464 about?
NCT07172464 is a clinical study titled "Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study". 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 ai...
What is the current status of trial NCT07172464?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-10-09. Estimated completion is 2031-02.
What conditions does trial NCT07172464 study?
This clinical trial studies the following conditions: Patent Foramen Ovale, PFO - Patent Foramen Ovale, Cryptogenic Stroke, PFO, PFO-associated Stroke.
What interventions are being tested in trial NCT07172464?
The interventions under investigation include: Recross P3 Occluder (P3O) System (DEVICE).
Who is sponsoring clinical trial NCT07172464?
This trial is sponsored by Recross Cardio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07172464 being conducted?
This trial has 5 study locations across California, Florida, Massachusetts, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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