P3 Occluder for Patent Foramen Ovale

(PROTEA-PFO Trial)

Recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Recross Cardio, Inc.

Must not be taking: Anticoagulants, Antiarrhythmics

Disqualifiers: Atherosclerosis, Arrhythmias, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart device called the P3 Occluder System to determine if it can safely and effectively close a small opening in the heart, known as a Patent Foramen Ovale (PFO), in individuals who have had a stroke possibly linked to this opening. The goal is to prevent future strokes related to PFO. Participants will have the P3 Occluder System implanted and will attend follow-up visits and calls over the next few years. This trial is suitable for adults diagnosed with a PFO who have experienced a stroke that doctors believe might be connected to the heart opening. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to new treatment options for stroke prevention.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you are unable to discontinue anticoagulation (blood-thinning) medications for reasons other than the stroke related to the trial.

What prior data suggests that the P3 Occluder System is safe for closing a PFO?

Research has shown that using devices to close a patent foramen ovale (PFO), a small opening in the heart, is generally safe. Studies have found that this procedure usually carries a low risk of complications. For instance, one study reported few problems during and after PFO closure, indicating minimal risk of negative effects.

While data on the P3 Occluder System specifically is limited, other PFO closure devices have demonstrated good safety records over time. These devices are designed to help prevent strokes related to PFOs and appear to do so without causing significant harm to patients. Although each device is unique, the overall safety of PFO closure treatments suggests that the P3 Occluder System might also be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Recross P3 Occluder (P3O) System is unique because it offers a new approach to closing a patent foramen ovale (PFO), which is a small hole in the heart that didn't close the way it should after birth. Unlike standard treatments that might involve surgical intervention, the P3O System is a transcatheter device, meaning it can be implanted without open-heart surgery. This minimally invasive delivery method potentially reduces recovery time and lowers the risk of complications. Researchers are excited about this treatment because it could reduce the risk of recurrent strokes in patients with PFO-associated strokes more effectively and safely than current options.

What evidence suggests that the P3 Occluder System is effective for closing a PFO in patients with stroke?

Research has shown that closing a patent foramen ovale (PFO), a small opening in the heart, can lower the risk of strokes in some patients. In this trial, participants will receive the Recross P3 Occluder (P3O) System, developed for transcatheter closure of a PFO to reduce the risk of recurrent ischemic stroke. Studies have found that devices like the Recross P3 Occluder effectively serve this purpose. For instance, the Amplatzer PFO Occluder, a similar device, proved safe and effective in preventing repeat strokes over the long term. Research on various PFO closure devices indicates that many patients experienced successful closure and fewer strokes afterward. This suggests that devices like the P3 Occluder could be promising in preventing strokes by closing the PFO. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for patients who've had a stroke possibly linked to a heart condition called Patent Foramen Ovale (PFO), which is a small opening between the heart's upper chambers. Participants must be suitable candidates for the implant procedure.

Inclusion Criteria

Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release

Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee

Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test

Exclusion Criteria

Life expectancy < 2 years

Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum and pulmonary arteriovenous malformation

Uncontrolled hypertension, defined as sustained elevated blood pressure >140/90 mm Hg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo the procedure to implant the P3 Occluder System, if deemed appropriate

1 day

1 visit (in-person)

Follow-up

Participants visit their doctor for follow-up exams at specified intervals

5 years

5 visits (in-person) at 1 month, 3 months, 6 months, 1 year, and 5 years; 3 phone calls at 2 years, 3 years, and 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Recross P3 Occluder (P3O) System

Trial Overview

The study tests the safety and effectiveness of the P3 Occluder System, a new device designed to close PFOs in stroke patients. It involves an implant procedure followed by multiple follow-up visits and phone surveys over five years.

How Is the Trial Designed?

Group I: Recross P3 Occluder (P3O) System Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Recross Cardio, Inc.

Lead Sponsor

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07172464

NCT07172464 | Early Feasibility Study (EFS) Evaluating ...

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 ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36165815/

Real world long-term outcomes among adults undergoing ...

We observed excellent safety and effectiveness outcomes for PFO closure conducted with Amplatzer PFO Occluder, similar to randomized controlled trials.

3.

eurointervention.pcronline.com

eurointervention.pcronline.com/article/efficacy-of-different-devices-for-transcatheter-closure-of-patent-foramen-ovale-assessed-by-serial-transoesophageal-echocardiography-and-rates-of-recurrent-cerebrovascular-events-in-a-long-term-follow-up

Efficacy of different devices for transcatheter closure ...

Study evaluates efficacy of different PFO closure devices in achieving complete closure and rates of recurrent cerebrovascular events.

4.

mdpi.com

mdpi.com/2077-0383/13/21/6354

Comparative Effectiveness of Devices for Interventional ...

Methods: This monocentric, retrospective study analyzed 716 patients who underwent PFO closure between January 2000 and February 2023. Data ...

5.

j-stroke.org

j-stroke.org/func/download.php?path=L2hvbWUvdmlydHVhbC9zdHJva2Uvam91cm5hbC91cGxvYWQvcGRmLy8uLi9lcHViL2pvcy0yMDE4LTAzMDk3LmVwdWI=&filename=am9zLTIwMTgtMDMwOTcuZXB1Yg==

Patent Foramen Ovale: Story Closed?

The Clinical Trial Comparing Percutaneous Closure of Patent Foramen Ovale (PFO) Using the Amplatzer PFO Occluder with Medical Treatment in ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/15033255/

Transcatheter closure of patent foramen ovale (PFO) in ...

Interventional PFO closure appears to be safe and a promising technique in symptomatic PFO patients with a low incidence of periinterventional complications.

7.

eurointervention.pcronline.com

eurointervention.pcronline.com/article/percutaneous-closure-of-the-patent-foramen-ovale-using-the-helex-septal-occluder-acute-and-long-term-results-in-405-patients

Percutaneous closure of the patent foramen ovale using ...

Study evaluates long-term outcomes of PFO closure using the HELEX Occluder system, finding low recurrent event rates and potential to prevent thrombus ...