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Heart device aims to cut stroke risk in PFO patients

NCT ID NCT03309332

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a device called the AMPLATZER PFO Occluder, which is implanted to close a hole in the heart (PFO) in people who have had a stroke. Over 1,200 participants are being followed for up to 5 years to see if the device prevents another stroke and is safe. The goal is to confirm the device works well in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AMPLATZER™ PFO Occluder (a device implanted to close a hole in the heart)
What this could lead to
If successful, this could confirm that the device effectively reduces the risk of another stroke in people with a PFO.
What could go wrong
This is a post-approval study, so the device is already approved. However, it may not work for everyone, and there are risks like device-related complications or serious adverse events.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1,214 people

The number who actually took part.

Started

Jan 2018

Expected to finish

Feb 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Subjects with a PFO who have had an ischemic stroke within the last 547 days Exclusion Criteria: * Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥ 50% lumen diameter supplying the involved lesion * Intra-cardiac thrombus or tumor * Documented evidence of venous thrombus in the vessels through which access to the PFO is gained * Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina * Left ventricular aneurysm or akinesis * Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology * Aortic valve stenosis (mean gradient \>40 mmHg) or severe aortic valve regurgitation * Mitral or aortic valve vegetation or prosthesis * Aortic arch plaques protruding greater than 4mm into the aortic lumen * Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%) * Subjects with other source of right to left shunts, including an atrial septal defect and/or fenestrated septum * Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter * Pregnancy at the time of implant * Age less than 18 years or greater than 60 years at time of consent * Active endocarditis or other untreated infections * Organ failure (kidney, liver or lung). Kidney failure: Poor urine output of less than 1 cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory at the investigational site). Liver failure: Liver enzymes outside the normal reference range for the laboratory at the investigational site: poor liver function as assessed by elevated PT (above the normal reference range for the laboratory at the investigational site) and low total protein and albumin (below the normal reference range for the laboratory at the investigational site). Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted ventilation. * Uncontrolled hypertension defined as sustained elevated systemic blood pressure to more than 160/90 mmHg with medications * Uncontrolled diabetes defined as continued elevated glucose levels in spite of administration of insulin/levels of more than 200 mg with presence of glucose in the urine * Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event Definition: Ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following: 1) a history of hypertension (except in the first week post stroke); 2) history of diabetes mellitus; 3) Age \>/= 50; or 4) MRI or CT shows leukoaraiosis greater than symmetric, well-defined periventricular caps or bands (European Task Force on Age-Related White Matter Changes rating scale score \> 0) * Arterial dissection as cause of stroke * Subjects who test positive with one of the following hypercoagulable states; Anticardiolipin Ab of the IgG or IgM (≥30), Lupus anticoagulant, B2-glycoprotein-1 antibodies (≥30) or persistently elevated homocysteine (\>20) * Unable to take antiplatelet therapy * Anatomy in which the AMPLATZERTM PFO Occluder device size required would interfere with intracardiac or intravascular structures such as valves or pulmonary veins * Vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size * Malignancy or other illness where life expectancy is less than 2 years * Subjects who will not be available for follow-up for the duration of the trial * Inability to obtain Informed Consent from patient * Index stroke of poor outcome (modified Rankin score greater than 3)

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Conditions

The condition(s) this trial relates to.

ischemic stroke patent foramen ovale stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Patent foramen ovale Stroke

Contacts and locations

Locations

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension Texas Cardiovascular Research

    Austin, Texas, 78705, United States

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Hospital East

    Louisville, Kentucky, 40515, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Baylor Scott & White - The Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • Centro Cardiologico Monzino

    Milan, Lombard, Italy

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224, United States

  • Charlton Memorial Hospital

    Fall River, Massachusetts, 02720, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Cleveland Clinic Florida

    Weston, Florida, 33331, United States

  • Denver Heart

    Denver, Colorado, 80031, United States

  • Deutsches Herzzentrum Berlin

    Berlin, State of Berlin, 13353, Germany

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37922, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9, Canada

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27358, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004, United States

  • HCA Midwest Division, Menorah Medical Center

    Overland Park, Kansas, 66209, United States

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48084, United States

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, H1T 1C8, Canada

  • Jewish Hospital

    Cincinnati, Ohio, 45236, United States

  • Johns Hopkins University Hospital

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027, United States

  • Kaiser Sunnyside Medical Center

    Clackamas, Oregon, 97015, United States

  • Kantonsspital St.Gallen

    Sankt Gallen, Stgalln, 9007, Switzerland

  • Lexington Medical Center

    West Columbia, South Carolina, 29169, United States

  • Los Robles Hospital and Medical Center

    Thousand Oaks, California, 91360, United States

  • McLaren Health Care Corporation

    Auburn Hills, Michigan, 48326, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Hospital of Colorado Springs

    Colorado Springs, Colorado, 80909, United States

  • Mercy Hospital South

    St Louis, Missouri, 63128, United States

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407, United States

  • Moses H Cone Memorial Hospital

    Greensboro, North Carolina, 27358, United States

  • Mount Sinai Hospital

    New York, New York, 10019, United States

  • Mt Carmel East

    Columbus, Ohio, 43213, United States

  • New York Presbyterian Hospital/ Cornell University

    New York, New York, 10021, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501, United States

  • Novant Health Heart and Vascular Research

    Charlotte, North Carolina, 28204, United States

  • Ochsner Medical Center

    New Orleans, Louisiana, 70448, United States

  • Ohio Health Research Institute

    Columbus, Ohio, 43210, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Orlando Health

    Orlando, Florida, 32806, United States

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Pima Heart Physicians, PC

    Tucson, Arizona, 85712, United States

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 63146, United States

  • Providence Heart and Vascular Institute

    Portland, Oregon, 97225, United States

  • Providence St. Patrick Hospital

    Missoula, Montana, 59802, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • San Diego Cardiac Center

    San Diego, California, 92123, United States

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57117, United States

  • Santa Maria Hospital

    Lisbon, Lisbon District, 1649-035, Portugal

  • Scottsdale Healthcare Shea

    Scottsdale, Arizona, 85260, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23112, United States

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120, United States

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St. Cloud Hospital

    Saint Cloud, Minnesota, 56303, United States

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013, United States

  • St. Mary's Hospital

    Duluth, Minnesota, 55805, United States

  • St. Thomas Hospital

    London, London, SE1 7EH, United Kingdom

  • St. Vincent's Medical Center

    Jacksonville, Florida, 32204, United States

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • Stony Brook University Medical Center

    Stony Brook, New York, 11790, United States

  • Sutter Medical Center

    Sacramento, California, 95816, United States

  • Swedish Medical Center - Heart & Vascular

    Seattle, Washington, 98122, United States

  • TUM Klinikum - Deutsches Herzzentrum München

    München, Bavaria, 80636, Germany

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee, 37920, United States

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

  • TriHealth Bethesda North Hospital

    Cincinnati, Ohio, 45242, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UAMS Medical Center

    Little Rock, Arkansas, 72205, United States

  • USC University Hospital

    Los Angeles, California, 90033, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California at San Francisco

    San Francisco, California, 94143, United States

  • University of Colorado Hospital

    Aurora, Colorado, 80045, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77074, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • University of Wisconsin Hospital

    Madison, Wisconsin, 53792, United States

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • WellStar Kennestone Hospital

    Marietta, Georgia, 98502, United States

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Other studies related to the condition(s) this trial covers.