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PFO Occluder

AMPLATZER PFO Occluder for Patent Foramen Ovale (PFO PAS Trial)

N/A

Recruiting

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

Left ventricular aneurysm or akinesis

Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years

Awards & highlights

Summary

This trial is to confirm the safety and effectiveness of a heart device called the AMPLATZER™ PFO Occluder in people who have had the device implanted already.

Who is the study for?

This trial is for people aged 18-60 who've had a stroke linked to a heart defect called PFO within the last 547 days. They must be able to take antiplatelet therapy and commit to follow-up visits. It's not for those with uncontrolled high blood pressure, certain heart conditions, severe infections, recent serious heart events, or other identified causes of stroke.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of the AMPLATZER™ PFO Occluder device in patients after it has been approved. This device is designed to close the PFO and potentially reduce the risk of future strokes.See study design

What are the potential side effects?

Possible side effects may include discomfort at the implant site, bleeding or bruising, irregular heartbeat, allergic reactions to device materials or medications used during procedure, and risks associated with heart catheterization like blood vessel damage.

Eligibility Criteria

Exclusion Criteria

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

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My heart has a weakened or bulging area.

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I have severe narrowing or leaking of my aortic valve.

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My heart's left ventricle is enlarged and pumps less effectively.

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My stroke was caused by a tear in my artery.

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I have a blood condition that makes my blood clot more easily.

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I have a heart condition that causes irregular heartbeats.

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I have kidney, liver, or lung failure as described.

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My high blood pressure is not controlled by medication and is over 160/90 mmHg.

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I have diabetes with high blood sugar levels despite taking insulin.

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My blood vessels are too small for the required medical device.

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My doctor expects me to live more than 2 years despite my illness.

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The device needed for my heart condition would interfere with my heart or blood vessels.

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I cannot take medication to prevent blood clots.

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My stroke has left me with significant disabilities.

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I do not have active endocarditis or other untreated infections.

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I have a blocked artery in my brain affecting more than half its width.

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I have a blood clot or tumor in my heart.

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I need treatment for a serious mitral valve issue.

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I am either younger than 18 or older than 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness: 5 year rate of recurrent ischemic stroke

Primary Safety: Device or procedure related serious adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: DeviceExperimental Treatment1 Intervention

Subjects implanted with the AMPLATZER™ PFO Occluder.

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor

644 Previous Clinical Trials

404,872 Total Patients Enrolled

Barathi Sethuraman, PhDStudy DirectorAbbott

1 Previous Clinical Trials

721 Total Patients Enrolled

Media Library

AMPLATZER™ PFO Occluder (PFO Occluder) Clinical Trial Eligibility Overview. Trial Name: NCT03309332 — N/A

Patent Foramen Ovale Research Study Groups: Device

Patent Foramen Ovale Clinical Trial 2023: AMPLATZER™ PFO Occluder Highlights & Side Effects. Trial Name: NCT03309332 — N/A

AMPLATZER™ PFO Occluder (PFO Occluder) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03309332 — N/A

~45 spots leftby Oct 2024

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