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New heart procedure tracked for 3 years in 580 patients

NCT ID NCT06578104

Disease control Sponsor: Medtronic Cardiac Ablation Solutions 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study follows 580 adults with atrial fibrillation who are treated with the PulseSelect PFA system, a device that uses electrical pulses to fix irregular heartbeats. Researchers will monitor participants for 36 months to see how well the procedure prevents heart rhythm problems and to check for any serious side effects. The goal is to confirm the device works safely in real-world use.

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 580 people

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

Started

Nov 2024

Expected to finish

Apr 2030

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

Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System

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 * A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF * Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired) * Patient is ≥ 18 years of age * Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System * Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements Exclusion Criteria * Long-standing persistent AF (continuous AF sustained \>12 months) * Prior left atrial catheter or surgical ablation * Patient with life expectancy \< 36 months * Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) * Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation persistent atrial fibrillation

As listed by the trial registrant

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

Atrial fibrillation

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 3 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

  • AnMed Health Center

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Beaumont Health System

    WITHDRAWN

    Royal Oak, Michigan, 48073, United States

  • Bethesda North Hospital

    RECRUITING

    Cincinnati, Ohio, 45220, United States

  • Confluence Health Hospital Central Campus

    RECRUITING

    Wenatchee, Washington, 98801, United States

  • Doylestown Health Cardiology a division of Doylestown Health Physicians

    RECRUITING

    Doylestown, Pennsylvania, 18901-2554, United States

  • Duke University Medical Center (DUMC)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Endeavor Health Swedish Hospital

    RECRUITING

    Chicago, Illinois, 60625, United States

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, 42601, South Korea

  • London Health Sciences Centre - University Campus

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425-8908, United States

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Mount Carmel Grove City Medical Center

    RECRUITING

    Grove City, Ohio, 43123, United States

  • Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • Northwell Health Lenox Hill Hospital

    RECRUITING

    New York, New York, 10075, United States

  • Piedmont Heart Institute

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pikeville Medical Center

    RECRUITING

    Whitesburg, Kentucky, 41858-7428, United States

  • Southcoast Health System

    RECRUITING

    Fall River, Massachusetts, 02720, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, Canada

  • Texas Health Research & Education Institute

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75231-3815, United States

  • The Ohio State University Wexner Medical Center

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 045218, United States

  • The Valley Hospital

    RECRUITING

    New York, New York, 10025, United States

  • University of South Florida Health (USF)

    RECRUITING

    Tampa, Florida, 33606-3603, United States

  • University of Virginia Medical Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

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