NCT07172464View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

February 28, 2031

Conditions
PFOPFO - Patent Foramen OvaleCryptogenic StrokePatent Foramen OvalePFO-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.

Trial Locations (4)

10032

NOT_YET_RECRUITING

Columbia University Medical Center/ NewYork Presbyterian Hospital, New York

29605

RECRUITING

Prisma Health - Upstate, Greenville

32669

RECRUITING

The Cardiac and Vascular Institute, Gainesville

02111

RECRUITING

Tufts Medical Center, Boston

All Listed Sponsors
collaborator

MCRA

INDUSTRY

lead

Recross Cardio, Inc.

INDUSTRY