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Can doctors safely perform multiple heart procedures in one day? new study investigates

NCT ID NCT06436924

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This observational study is tracking 678 people with atrial fibrillation who are getting a Watchman device implanted to close off the left atrial appendage and reduce stroke risk. The study focuses on centers where a single doctor performs eight or more of these procedures in one day. Researchers will compare complication rates and device success to historical data to see if high-volume scheduling is safe and effective.

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 or Watchman FLX Pro left atrial appendage occlusion device
What this could lead to
If successful, this study could show that scheduling many LAAO procedures in one day is safe and effective, potentially improving access to stroke prevention for atrial fibrillation patients.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. Outcomes depend on operator skill and patient selection, and complications like bleeding or device leakage remain possible.

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

569 people

The number who actually took part.

Started

May 2024

Finished

Mar 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

The study population will include subjects who are clinically qualified for a Watchman FLX™ or Watchman FLX Pro™ LAAO device implant and would receive one regardless of participation in the study, who meet all eligibility criteria for the study, and present at participating institutions for a LAAO device implant procedure on a day in which a single implanting physician scheduled at least eight LAAO device implant procedures, regardless of the device manufacturer (i.e., high-volume).

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. 18 years of age or older 2. Able and willing to participate in baseline and follow up evaluations for the full length of the study 3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device 4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care 5. Having their LAAO device implant procedure scheduled on a qualifying high-volume\* procedure day as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date \*high-volume - a calendar day in which the single implanting physician schedules ≥ 8 LAAO device implant procedures, regardless of the device manufacturer 6. Willing and able to provide informed consent Exclusion Criteria: 1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan 2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure 3. Having their LAAO device implant procedure scheduled on a day in which the single implanting physician scheduled \< 8 LAAO device implant procedures as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date

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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.

Atrial fibrillation

Contacts and locations

Locations

  • Ascension St. Vincent

    Jacksonville, Florida, 32204, United States

  • Grandview Medical Center

    Birmingham, Alabama, 35243, United States

  • Medical University of South Carolina

    Columbia, South Carolina, 29204, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Naples Community Hospital

    Naples, Florida, 34102, United States

  • Pima Heart and Vascular

    Tucson, Arizona, 85704, United States

  • The Medical Center of Aurora

    Aurora, Colorado, 80012, United States

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