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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness: 5 year rate of recurrent ischemic stroke
Primary Safety: Device or procedure related serious adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DeviceExperimental Treatment1 Intervention
Subjects implanted with the AMPLATZER™ PFO Occluder.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
650 Previous Clinical Trials
410,129 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
~157 spots leftby Nov 2025
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