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One-Shot fix for AFib? study tests ablation plus watchman in same session

NCT ID NCT07041125

Disease control Sponsor: Heart Rhythm Clinical and Research Solutions, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 01, 2026 · Updated 6 times

Summary

This study looks at whether doing two procedures at once—pulsed field ablation (FARAPULSE) to fix irregular heartbeats and implanting a Watchman device to close off a part of the heart where clots form—is as safe as doing them separately. About 120 people with atrial fibrillation who are eligible for both treatments will take part. The goal is to see if the combined approach leads to fewer complications and better outcomes.

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

122 people

The number who actually took part.

Started

Jun 2025

Finished

Jun 2026

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

Patients eligible for the main DISRUPT-AF Registry with a planned concomitant LAAC procedure using the Watchman FLX™ Pro device

Ages

18 years and older

Sex

Anyone

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 inclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study must meet the additional inclusion criteria below: * Patients who are determined by physicians to be eligible for LAAC * Patients whose LAAC with Watchman FLX Pro procedures are performed concomitant following AF ablation procedure * Willing and able to provide additional informed consent to the sub-study (unless waiver of consent is obtained) Exclusion Criteria: All exclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study have the additional exclusion criteria below: -Patients who are participating in other DISRUPT-AF sub-studies

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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.

Pfa ablation and laac procedures

Contacts and locations

Locations

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Arrhythmia Center of South Florida

    Delray Beach, Florida, 33484, United States

  • Arrhythmia Institute at Grandview

    Birmingham, Alabama, 35243, United States

  • Ascension St Vincent -Indianapolis Ascension Health

    Indianapolis, Indiana, 46184, United States

  • Ascension St. Vincent's Jacksonville

    Jacksonville, Florida, 32204, United States

  • California Pacific Medical Center Sutter Health

    San Francisco, California, 94109, United States

  • Chippenham Hospital)

    Richmond, Virginia, 23225, United States

  • HCA Research Institute- Mercy Hospital

    Miami, Florida, 37203, United States

  • Norton Heart & Vascular Institute

    Louisville, Kentucky, 40205, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120, United States

  • St, Mark's Hospital

    Salt Lake City, Utah, 84124, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Heart Rhythm Center of Mississippi

    Gulfport, Mississippi, 39502, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

More trials for these conditions

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