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Heart hole closer may cut stroke risk in mystery cases

NCT ID NCT03821129

Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study tests a device called GORE® CARDIOFORM Septal Occluder to close a small hole in the heart (PFO) in people who have had a stroke with no clear cause. About 636 participants will get the device plus blood-thinning medicine. The goal is to see if this reduces the chance of having another stroke and to check for any serious side effects.

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

About 636 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Oct 2031

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 70 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: * Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment. * Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver. * Patient is able to tolerate antiplatelet therapy * Note: Additional Inclusion Criteria may apply Exclusion Criteria: * History of or ongoing atrial fibrillation/flutter * Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of \<40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD) * Previous Myocardial Infarction * Rankin Scale sore greater than or equal to 3 at the time of procedure * Active infection that cannot be treated successfully prior to enrollment * Neurological deficits not due to stroke that may affect the patient's neurologic assessments * Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure * Sensitivity or contraindication to all proposed medical treatments or any device components * Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment. * Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device. * Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder * Need for concomitant procedure(s) that may confound detection of adverse events related to device placement * Note: Additional Exclusion Criteria may apply

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Conditions

The condition(s) this trial relates to.

ischemic stroke patent foramen ovale stroke disorder prevention target

As listed by the trial registrant

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

Pfo - patent foramen ovale Stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alexian Brothers Medical Center

    WITHDRAWN

    Elk Grove Village, Illinois, 60007, United States

  • Atrium Health

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Aurora Health Care, Metro Inc.

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Baptist Health Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Baylor College of Medicine-Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Baylor Scott & White Memorial Hospital

    RECRUITING

    Temple, Texas, 76508, United States

  • Catholic Health Initiatives- Iowa Corp dba Iowa Heart

    RECRUITING

    West Des Moines, Iowa, 50266, United States

  • Charleston Area Medical Center (CAMC)

    RECRUITING

    Charleston, West Virginia, 25302, United States

  • Cleveland Clinic Florida

    ACTIVE_NOT_RECRUITING

    Weston, Florida, 33331, United States

  • Columbia University Medical Center/NYPH

    TERMINATED

    New York, New York, 10032, United States

  • Covenant Medical Center, Inc.

    TERMINATED

    Saginaw, Michigan, 48602, United States

  • Emory University

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Jersey Shore University / Hackensack UMC

    WITHDRAWN

    Freehold, New Jersey, 07728, United States

  • Lehigh Valley Hospital

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Loma Linda University Health

    RECRUITING

    Loma Linda, California, 92354, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical Center of the Rockies

    RECRUITING

    Loveland, Colorado, 80538, United States

  • Medical College of Wisconsin, Inc.

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    WITHDRAWN

    Charleston, South Carolina, 29425, United States

  • Methodist Healthcare Systems of San Antonio d/b/a Methodist Hospital

    ACTIVE_NOT_RECRUITING

    San Antonio, Texas, 78229, United States

  • Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital

    RECRUITING

    Minneapolis, Minnesota, 55407, United States

  • Multicare Health Tacoma-Multicare Institute for Research & Innovation

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Naples Community Hospital

    RECRUITING

    Naples, Florida, 34102, United States

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • Providence Heart & Vascular Institute

    RECRUITING

    Portland, Oregon, 97225, United States

  • Research Foundation SUNY Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Santa Barbara Cottage Hospital

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Scripps Health La Jolla

    RECRUITING

    La Jolla, California, 92037, United States

  • Sentara Cardiovascular Research Institute

    TERMINATED

    Norfolk, Virginia, 23455, United States

  • South Denver Cardiology Associates

    RECRUITING

    Littleton, Colorado, 80120, United States

  • St. Marks Hospital

    RECRUITING

    Salt Lake City, Utah, 84124, United States

  • St. Mary's Hospital

    WITHDRAWN

    Tucson, Arizona, 85745, United States

  • Tennova Healthcare

    WITHDRAWN

    Knoxville, Tennessee, 37934, United States

  • The Methodist Hospital - Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California - San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Iowa Hospitals & Clinic

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    WITHDRAWN

    Edina, Minnesota, 55435, United States

  • University of SF (Tampa General Hospital)

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    TERMINATED

    Nashville, Tennessee, 37232, United States

  • William Beaumont Hospital

    WITHDRAWN

    Royal Oak, Michigan, 48073, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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