What is the mechanism of action of this treatment?

The most common treatments for Patent Foramen Ovale (PFO) include medical management with antiplatelet or anticoagulant medications and physical closure using devices. Closure devices, like the Encore PFO Closure Device, work by physically sealing the PFO to prevent abnormal blood flow between the atria. This is crucial for PFO patients as it reduces the risk of paradoxical embolism, which can lead to strokes or other serious complications. By effectively closing the PFO, these devices help restore normal blood flow and reduce the likelihood of embolic events, thereby improving patient outcomes.

What side effects are associated with this type of intervention?

Common side effects of PFO closure devices, such as the Encore PFO Closure Device, include atrial fibrillation, device-related thrombus formation, and vascular complications at the catheter insertion site. Other potential risks are device embolization, residual shunting, and headaches post-procedure.

What prior FDA approvals exist?

The FDA has approved several devices for the treatment of Patent Foramen Ovale (PFO), which physically seal the PFO to prevent abnormal blood flow. Notable among these are the Amplatzer PFO Occluder and the Gore Cardioform Septal Occluder. These devices are designed to close the PFO and reduce the risk of recurrent stroke in patients who have had a cryptogenic stroke. The Encore PFO Closure Device, currently under study, aims to establish its safety and effectiveness compared to these existing FDA-approved devices.

What other types of research exist?

Promising novel alternatives to the Encore PFO Closure Device for PFO patients in 2024 include: 1) The GORE CARDIOFORM Septal Occluder, which has shown high success rates and low complication rates in clinical trials. 2) The Amplatzer PFO Occluder, which is widely used and has a strong track record of safety and efficacy. 3) The NobleStitch EL, a suture-based closure system that offers a minimally invasive approach without leaving a metal implant. These alternatives provide effective options for PFO closure with varying benefits in terms of invasiveness and long-term outcomes.

← Back to Search

PFO Closure Device

Encore PFO Closure Device for Patent Foramen Ovale

N/A

Recruiting

Led By Christopher D Nielsen, MD

Research Sponsored by Encore Medical Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cryptogenic stroke within the last 270 days; stroke is defined as acute focal neurological deficit, presumed to be due to focal ischemia, and confirmed by MRI or CT to be a new, neuroanatomically relevant cerebral infarct

Be between 18 and 65 years old

Must not have

Intracardiac thrombus or tumor

Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of the Encore PFO closure device, which is used to close a small hole in the heart. It targets patients who have had strokes with no clear cause, likely due to blood clots passing through this hole. The device is inserted through a thin tube, avoiding the need for open-heart surgery.

Who is the study for?

Adults aged 18-60 with a recent cryptogenic stroke and diagnosed Patent Foramen Ovale (PFO) can join. They must have had a stroke within the last 270 days confirmed by MRI or CT, without other known causes of stroke, no severe heart issues, uncontrolled blood pressure or diabetes, clotting disorders, nickel allergy, or severe kidney/liver disease.

What is being tested?

The trial is testing the safety and effectiveness of the Encore PFO closure device compared to any FDA-approved PFO closure device for preventing strokes in people with PFO. Participants will be randomly assigned to receive either the Encore device or another approved device.

What are the potential side effects?

Potential side effects may include discomfort at the insertion site, allergic reactions to materials like nickel or contrast used during procedures, irregular heartbeat risks associated with heart devices, and less commonly complications such as blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a stroke with unknown cause in the last 270 days, confirmed by MRI or CT.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a blood clot or tumor in my heart.

Select...

My kidney function is very low or I am on dialysis.

Select...

My heart has a weakened or bulging area.

Select...

I cannot or do not want to give permission for treatment.

Select...

I have severe liver disease or cirrhosis.

Select...

I am either younger than 18 or older than 60.

Select...

My stroke has a known cause like heart issues or specific artery conditions.

Select...

I need blood thinners due to a clotting disorder confirmed by specific blood tests.

Select...

My most recent HbA1c level was 9 or higher.

Select...

I do not have any bleeding disorders.

Select...

My heart's mitral valve is narrow or leaks severely.

Select...

I cannot take aspirin or clopidogrel due to health reasons.

Select...

I need to use oxygen at home all the time.

Select...

I cannot undergo TEE due to my body's structure.

Select...

I expect to need treatment for a heart defect other than a hole between heart chambers.

Select...

I need surgery for a heart condition.

Select...

I have severe narrowing or leaking of the aortic valve in my heart.

Select...

I have a history of atrial fibrillation or flutter.

Select...

I do not have any untreated infections or active endocarditis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness: Effective closure

Secondary study objectives

Complete closure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Encore PFO closure deviceExperimental Treatment1 Intervention

Group II: Any FDA-approved PFO closure device chosen by the investigatorActive Control1 Intervention

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Patent Foramen Ovale (PFO) include medical management with antiplatelet or anticoagulant medications and physical closure using devices. Closure devices, like the Encore PFO Closure Device, work by physically sealing the PFO to prevent abnormal blood flow between the atria. This is crucial for PFO patients as it reduces the risk of paradoxical embolism, which can lead to strokes or other serious complications. By effectively closing the PFO, these devices help restore normal blood flow and reduce the likelihood of embolic events, thereby improving patient outcomes.