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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Recross Cardio, Inc.
Study ID
NCT07172464
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Recross P3 Occluder (P3O) System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 9, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Feb 28, 2031

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: 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.

Primary Outcome Measure

Primary Safety Endpoint - Rate of Major Adverse Cardiovascular Events (MACE) [ Time Frame: 30 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Cynthia Santellan
[email protected]
310-794-4797
The Cardiac and Vascular InstituteGainesvilleFlorida32669
Marti Roberson
[email protected]
352-244-0208
Tufts Medical CenterBostonMassachusetts02111
Peter Zazzali
[email protected]
617.636.6140
Columbia University Medical Center/ NewYork Presbyterian HospitalNew YorkNew York10032
Rose Adelman
[email protected]
917-789-3945
Prisma Health - UpstateGreenvilleSouth Carolina29605
Abigail Anderson
[email protected]
864-455-7629

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CAThe Cardiac and Vascular Institute· Gainesville, FLTufts Medical Center· Boston, MAColumbia University Medical Center/ NewYork Presbyterian Hospital· New York, NYPrisma Health - Upstate· Greenville, SC

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