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New device shows promise in preventing strokes for heart patients

NCT ID NCT05809596

Disease control Sponsor: Boston Scientific Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tracked 949 patients with non-valvular atrial fibrillation who received the WATCHMAN FLX Pro device, a small implant that closes off a part of the heart to reduce stroke risk. The goal was to see how well the device works in everyday medical practice, focusing on safety and effectiveness. Researchers measured device leaks and serious events like stroke, bleeding, or death over six months.

What this could mean

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

Active substance
WATCHMAN FLX Pro left atrial appendage closure device
What this could lead to
If successful, this could confirm that the WATCHMAN FLX Pro device is a safe and effective option for preventing strokes in people with atrial fibrillation who cannot take blood thinners long-term.
What could go wrong
This is a post-market observational study, not a randomized trial, so results may be influenced by patient selection. The device may still carry risks like device leak, stroke, or major bleeding.

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

949 people

The number who actually took part.

Started

Oct 2023

Finished

Sep 2025

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: * Subject is of legal age to participate in the study. * Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve). * Subject is clinically indicated for and is treated or attempted to be treated with a WATCHMAN FLX™ Pro device. * Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study. * Subject is able and willing to return for required follow-up visits and examinations. Exclusion Criteria: * Subject has a documented life expectancy of less than 6 months. * Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment. * Intracardiac thrombus is present. * An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. * The LAA anatomy will not accommodate a Closure Device. * The patient has known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN FLX™ Pro Device is contraindicated. * Any of the customary contraindications for other percutaneous catheterization procedure (e.g., patient size too small to accommodate transesophageal echocardiography (TEE) probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present. * There are contraindications to the use of anticoagulation therapy, aspirin, or P2Y12 inhibitor. * Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage hemorrhagic disease stroke disorder prevention target

As listed by the trial registrant

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

Atrial fibrillation Bleeding Stroke

Contacts and locations

Locations

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Ascension Saint Thomas

    Nashville, Tennessee, 37203, United States

  • Baptist Memorial Hospital-Memphis / Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cardiology Associates of Fairfield County, P.C.

    Norwalk, Connecticut, 06851, United States

  • Centennial Medical Center

    Nashville, Tennessee, 37203, United States

  • Christus Trinity Mother Frances

    Tyler, Texas, 75701, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana, 46250, United States

  • Corewell Health

    Grand Rapids, Michigan, 49525, United States

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270, United States

  • Emory University

    Atlanta, Georgia, 30342, United States

  • Erlanger Health, Inc.,

    Chattanooga, Tennessee, 37403, United States

  • Good Samaritan Hospital

    Los Angeles, California, 90017, United States

  • Grandview Medical Center/ Affinity Cardiovascular Specialists

    Birmingham, Alabama, 35243, United States

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042, United States

  • Kaleida Health - Gates Vascular Institute

    Buffalo, New York, 14203, United States

  • Los Robles Hospital & Medical Center

    Thousand Oaks, California, 91360, United States

  • Manatee Memorial Hospital

    Bradenton, Florida, 34205, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medstar Washington Hospital Center

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

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Memorial Hermann Memorial City Medical Center

    Houston, Texas, 77094, United States

  • Methodist Hospital

    San Antonio, Texas, 78229, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114, United States

  • Novant Health Heart & Vascular Institute

    Charlotte, North Carolina, 28204, United States

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018, United States

  • Rochester General Hospital

    Rochester, New York, 14621, United States

  • Saint Luke's Health System

    Kansas City, Missouri, 64111, United States

  • Sanger Heart and Vascular Institute-Carolinas Medical Center

    Charlotte, North Carolina, 28204, United States

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • Scripps Memorial Hospital

    La Jolla, California, 92307, United States

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124, United States

  • Straub Medical Center

    Honolulu, Hawaii, 96813, United States

  • Texas Cardiac Arrhythmia Research

    Austin, Texas, 78705, United States

  • Tucson Medical Center

    Tucson, Arizona, 85712, United States

  • UC Health Memorial Hospital Central

    Colorado Springs, Colorado, 80909, United States

  • UPMC Pinnacle Health at Harrisburg Hospital

    Mechanicsburg, Pennsylvania, 17050, United States

  • University of Alabama Medical Center

    Birmingham, Alabama, 35233, United States

  • University of Kansas Health System

    Kansas City, Kansas, 66160, United States

  • Virtua Health

    Marlton, New Jersey, 08053, United States

  • WellSpan York Hospital

    York, Pennsylvania, 17403, United States

More trials for these conditions

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