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

NCT07172464 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-04

No results posted yet for this 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.

Conditions

  • PFO
  • PFO - Patent Foramen Ovale
  • Cryptogenic Stroke
  • Patent Foramen Ovale
  • PFO-associated Stroke

Interventions

DEVICE

Recross P3 Occluder (P3O) System

The Recross P3 Occluder (P3O) is being developed for the purpose of transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients with PFO-associated stroke.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Recross Cardio, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2026-08-31
Completion
2031-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07172464 on ClinicalTrials.gov