New device shows promise in preventing strokes for heart patients

NCT ID NCT05809596

Completed Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

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.

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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

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