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New heart device aims to cut stroke risk in AFib patients

NCT ID NCT06168942

Disease control Sponsor: Biosense Webster, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 4 times

Summary

This study tests a new device (Laminar) to close the left atrial appendage, a small pouch in the heart, in 1500 people with non-valvular atrial fibrillation. The goal is to see if it is safer and works better than existing devices to reduce the risk of stroke and blood clots. Participants must have a high stroke risk score and be recommended for the 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

About 1,500 people

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

Started

Feb 2024

Expected to finish

Feb 2032

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 years and older

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: * Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF) * CHA2DS2-VASc score greater than or equal to (\>=) 2 in men and \>= 3 in women * Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care * Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative * Eligible for the protocol-specified post-procedural antithrombotic regimen * Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements Exclusion Criteria: * Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) * Prior cardiac surgery or any procedure that involved pericardial access * Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliters per minute per (mL/min)/1.73 square meters (m\^2) or participants with end stage renal disease who are dialysis dependent * Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery) * Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)

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Conditions

The condition(s) this trial relates to.

atrial fibrillation stroke disorder prevention target

As listed by the trial registrant

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

Non valvular atrial fibrillation Stroke Systemic embolism

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG

    Phoenix, Arizona, 85018, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Ascension via Christi Hospitals Wichita Inc

    Wichita, Kansas, 67214, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Bethesda North Hospital Trihealth

    Cincinnati, Ohio, 45202, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Columbia University in the City of New York and The New York and Presbyterian Hospital

    New York, New York, 10032, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Heart Rhythm Associates

    Shenandoah, Texas, 77380, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Lindner Clinical Trial Center/Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NCH Healthcare

    North Naples, Florida, 34102, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwell Health

    Bay Shore, New York, 11706, United States

  • Ohio Health

    Columbus, Ohio, 43214, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Piedmont Healthcare

    Atlanta, Georgia, 30309, United States

  • Providence Saint John's Health Center and the Pacific Heart Institute

    Santa Monica, California, 90404, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Scripps Health

    San Diego, California, 92121, United States

  • St Joseph Hospital and Medical Center

    Tacoma, Washington, 98405, United States

  • Stanford Health Care

    Palo Alto, California, 94303, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Kansas City Heart Rhythm Institute

    Overland Park, Kansas, 66211, United States

  • Trident Medical Center

    North Charleston, South Carolina, 29406, United States

  • Tucson Medical Center

    Tucson, Arizona, 85712, United States

  • Univeristy of California Davis Health

    Rancho Cordova, California, 95670, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    Charlotte, North Carolina, 28203, United States

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