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RECRUITING NA

Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study

NCT07172464 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 15 participants
Start Date 2025-10-09
Est. Completion 2031-02
Phase NA

Sponsor

Recross Cardio

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07172464

The ClinicalTrials.gov registry entry for NCT07172464 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Recross Cardio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07172464 reports 5 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07172464?

The interventions under investigation include: Recross P3 Occluder (P3O) System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07172464?

This trial is sponsored by Recross Cardio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial