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New heart implant aims to cut stroke risk without blood thinners

NCT ID NCT07262255

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 03, 2026 · Updated 8 times

Summary

This study is tracking 1000 people with atrial fibrillation who receive the WATCHMAN FLX Pro device, a small implant that closes off a part of the heart to prevent blood clots from causing strokes. The goal is to see how safe and effective the device is in everyday medical practice, especially for patients who cannot take long-term blood thinners. Researchers will monitor for serious events like stroke, bleeding, or death within a week of the procedure.

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 device (a left atrial appendage closure implant)
What this could lead to
If successful, this registry could confirm that the device safely reduces stroke risk and bleeding events in people with atrial fibrillation who cannot take blood thinners.
What could go wrong
This is an observational registry, not a controlled trial, so results may not prove cause and effect. There are procedural risks like bleeding, stroke, or need for emergency surgery.

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.

Participants

About 1,000 people

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

Started

Dec 2025

Expected to finish

Sep 2028

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.

Who is studied

Hospital

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: 1. Subject is attempted to be treated with the WATCHMAN FLX™ Pro LAAC device. 2. Subject has non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve) and is clinically indicated for a WATCHMAN FLX™ Pro LAAC device, per the Instructions for Use (IFU). 3. Subject or legal representative who are willing and capable of providing informed consent. 4. Subject is able and willing to return for required follow-up visits and examinations. 5. Subject whose age is 18 years or above, or who is of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Subject has a documented life expectancy of less than 12 months. 2. Subject who is currently enrolled in another investigational study or registry except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. 3. Intracardiac thrombus is present. 4. An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present. 5. The LAA anatomy will not accommodate a Closure Device. 6. Subject has a known hypersensitivity or contraindications according to IFU. 7. Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

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

Left atrial appendage closure Non-valvular atrial fibrillation (AF)

How to take part

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

  1. The places running it

    20 sites in 6 countries. 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

  • Aarhus University Hospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, 22763, Germany

  • Asklepios Klinik Nord Heidberg

    RECRUITING

    Hamburg, 22417, Germany

  • Asklepios Klinik Saint Georg

    RECRUITING

    Hamburg, 20099, Germany

  • Azienda Ospedaliero Universitaria Policlinico "G. Rodolico-San Marco

    RECRUITING

    Catania, 95123, Italy

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, 20138, Italy

  • Charite, Campus Benjamin Franklin

    RECRUITING

    Berlin, 12203, Germany

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Complejo Hospitalario Universitario de Pontevedra

    RECRUITING

    Pontevedra, 36001, Spain

  • Complejo Hospitalario de Pontevedra

    RECRUITING

    Pontevedra, 36001, Spain

  • Herz-und Diabeteszentrum Nordrhein-Westfalen

    RECRUITING

    Bad Oeynhausen, 32545, Germany

  • Hospital Clinico Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital de Leon

    RECRUITING

    León, 24071, Spain

  • INSELSPITAL - Universitätsspital Bern

    RECRUITING

    Bern, CH-3010, Switzerland

  • Kath Krankenhaus St Johann Nepomuk

    RECRUITING

    Erfurt, 99097, Germany

  • Ospedale Sacro Cuore Don Calabria

    RECRUITING

    Verona, 37126, Italy

  • Rigshospitalet Copenhagen

    RECRUITING

    Copenhagen, 2100, Denmark

  • Universitaetsklinikum Schleswig-Holstein

    RECRUITING

    Lübeck, 23582, Germany

  • University Hospital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 61-848, Poland

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