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New device plugs heart holes without open surgery

NCT ID NCT02985684

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a special device (GORE® CARDIOFORM ASD Occluder) to close a common type of hole in the heart called an atrial septal defect (ASD). The goal was to see if the device could safely and effectively seal the hole using a tube inserted through a blood vessel, avoiding open-heart surgery. 125 people with a hole between 8-35 mm took part. The main results showed that at 6 months, the device successfully closed the hole in most participants, with few serious problems related to the device or procedure.

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

125 people

The number who actually took part.

Started

Mar 2017

Finished

Sep 2022

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: All responses must be Yes to be eligible: 1. Patient has an ostium secundum ASD with evidence of left-to-right shunt and right ventricular volume overload. 2. Patient has a defect size 8-35 mm as measured directly by stop-flow balloon sizing. 3. Patient vasculature can accommodate the delivery system and procedural accessories. 4. Patient can accommodate TEE or intracardiac echocardiography (ICE) probe for implant procedure. 5. Patient is judged by the implanting physician to have adequate septal rims to retain the study device. 6. Patient (or legal guardian, if patient is a minor) will voluntarily sign a Patient Informed Consent Form (ICF) specific to the study. The Patient ICF must be reviewed and approved in a manner that complies with requirements of the hospital's Institutional Review Board (IRB). 7. Patient (and legal guardian, if patient is a minor) is physically and mentally willing to comply with all study follow-up requirements through 36 months, including routinely scheduled diagnostic testing and physical examinations. Exclusion Criteria: All responses must be No to be eligible: 1. Patient has significant known pre-existing electrophysiologic or structural cardiovascular defect, or other comorbidities that could elevate morbidity or mortality beyond what is common for ASD or would require surgical treatment within three (3) years of device placement. Examples include, but are not limited to, large ventricular septal defect, hypoplastic left heart syndrome, coarctation, univentricular heart or tricuspid atresia, pulmonary hypertension, coronary artery disease, valvular or myocardial dysfunction, and other congenital heart disease requiring surgical repair. 2. Patient has systemic or inherited conditions that would significantly increase risk of major morbidity and mortality during the term of the study. Examples include endocarditis, cancer, degenerative neuromuscular disorder, cardiomyopathy, and any condition expected to result in significant deterioration of health within three (3) years of the index procedure. 3. Patient has anatomy where the size or position of the occluder would interfere with other intracardiac or intravasculature structures, such as cardiac valves or pulmonary veins. 4. Patient has active endocarditis, other infections producing bacteremia, or has known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement. 5. Patient has known intracardiac thrombi. 6. Patient has an uncontrolled arrhythmia with evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia while under rate control or atrial fibrillation while under rhythm control) or requires electrophysiology study or concomitant intervention with device placement. 7. Patient is awaiting a procedure that requires trans-septal left atrial access within 6 months of implant procedure. 8. Patient has a history of stroke resulting in a significant morbidity or disability. 9. Patient is pregnant or lactating at time of screening. 10. Patient has contraindication to antiplatelet and anticoagulant medications. 11. Patient has elevated pulmonary vascular resistance (PVR) which in the opinion of the implanting physician precludes safe defect closure. 12. Patient has multiple defects based on screening imaging and stop-flow balloon sizing that would require placement of more than one device.

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Conditions

The condition(s) this trial relates to.

atrial septal defect atrial septal defect, ostium secundum type

As listed by the trial registrant

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

Atrial septal defect

Contacts and locations

Locations

  • Atrium Health

    Charlotte, North Carolina, 28203, United States

  • Children's Healthcare at Egleston

    Atlanta, Georgia, 30322, United States

  • Children's Hospital & Regional Medical Center

    Seattle, Washington, 98105, United States

  • Children's Hospital Boston

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19014, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Nicklaus Children's Hospital

    Miami, Florida, 33155, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital of Colorado

    Aurora, Colorado, 80218, United States

  • University of California-Los Angeles

    Los Angeles, California, 90095, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Utah

    Salt Lake City, Utah, 84113, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06520, United States

More trials for these conditions

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