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Heart plug may help AF patients with stomach bleeding avoid blood thinners

NCT ID NCT06052358

Disease control Sponsor: Kansas City Heart Rhythm Research Foundation 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study looked at using the WATCHMAN FLX device, a small plug placed in the heart, to prevent strokes in people with atrial fibrillation (an irregular heartbeat) who also had serious gastrointestinal (GI) bleeding. The device is meant to close off a part of the heart where clots often form, so patients might not need long-term blood thinners that can cause bleeding. The study planned to compare 250 patients who got the device to 250 similar patients who did not, but it was stopped early and enrolled only 73 people.

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 device
What this could lead to
If successful, this could offer a way to manage stroke risk in atrial fibrillation patients who have had serious GI bleeding, potentially reducing the need for blood thinners.
What could go wrong
This is a small, non-randomized registry that was terminated early, so results may be limited. The device itself carries risks like blood clots or leaks, and it may not fully prevent bleeding or stroke.

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

73 people

The number who actually took part.

Started

Aug 2023

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 250 patients who will undergo LAAC with Watchman FLX device and have a history of AF and GI bleed will be enrolled. This group will be compared to a historical cohort group of 250 patients with AF and recurrent gastrointestinal bleeding without LAAC.

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: * All male and female patients who are \> 18 years of age * Have Atrial Fibrillation * Have CHADS2VASc \> 2 * Have history of GI bleeding OR hospital admission that required blood transfusion OR emergency room visit requiring stopping of OAC OR outpatient 2 gm of Hgb drop from baseline, with or without evidence of upper or lower GI bleeding and requiring endoscopic procedure with holding of OAC. * Ability to understand study procedures and to comply with them for the entire length of the study. Exclusion Criteria: * Inability or unwillingness of individual to give written informed consent. * Other indications for OAC like deep vein thrombosis (DVT) or Pulmonary embolism (PE) or mechanical heart valve. * Patient who is pregnant will be excluded (Pregnancy will be excluded by checking urine beta-HCG). * Patient not following up with our practice / clinic after the procedure

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Gastrointestinal Hemorrhage

As listed by the trial registrant

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

Atrial fibrillation Gi bleeding

Contacts and locations

Locations

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas, 66211, United States

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66215, United States

  • Research Medical Center

    Kansas City, Missouri, 64032, United States

  • Research Medical Center Clinic

    Kansas City, Missouri, 64032, United States

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