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New heart ablation tech tracked in 10,000-Patient registry

NCT ID NCT06335082

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 6 times

Summary

This registry is following 10,000 people with atrial fibrillation who are getting a procedure called pulsed field ablation using the Farapulse system. The goal is to see how well it stops irregular heart rhythms and how safe it is in everyday medical practice. Researchers will track patients for long-term results and any complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pulsed field ablation using the Farapulse system
What this could lead to
If successful, this registry could confirm that Farapulse ablation is a safe and effective way to control atrial fibrillation without long-term medication.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. Risks include procedure-related complications like bleeding or heart rhythm issues.

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 10,000 people

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

Started

Apr 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

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 presenting at participating sites for atrial fibrillation ablation that meet all inclusion criteria.

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: * Patients who, in the opinion of the Investigator, are candidates for ablation for AF * Plans to undergo an ablation procedure using the FARAPULSE Pulsed Field Ablation System manufactured by Boston Scientific (as of July 1, 2026, patients enrolled must have procedures completed using the OPAL HDx mapping system, unless the subject is participating in a sub-study not requiring OPAL usage) * De Novo or repeat procedure using the FARAPULSE Pulse Field Ablation System. * 18 years of age or older * Able and willing to participate in baseline and follow up evaluations for the full length of the registry Exclusion Criteria: * Enrolled in an investigational drug or device trial, or any trial that dictates the treatment plan without prior approval from Sponsor * Currently receiving inotropic or mechanical support for Stage IV congestive heart failure, cardiogenic and/or septic shock. * In the opinion of the Investigator, any known contraindication to an ablation procedure or to any device or drug required for use during an ablation procedure as assessed by the Investigator

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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

How to take part

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

  1. The places running it

    36 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Arrhythmia Institute at Grandview

    Birmingham, Alabama, 35243, United States

  • Arrhythmia Research Group

    Jonesboro, Arkansas, 72401, United States

  • Ascension St Vincent -Indianapolis Ascension Health

    Indianapolis, Indiana, 46184, United States

  • Ascension St. Thomas Nashville

    Nashville, Tennessee, 37203, United States

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204, United States

  • Ascension Texas Cardiovascular

    Austin, Texas, 78705, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CHRISTUS Trinity Mother Frances Health System

    Tyler, Texas, 75701, United States

  • Cardiovascular Associates of Delaware Valley

    Haddon Heights, New Jersey, 08035, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Community Memorial Health Systems

    Ventura, California, 93003, United States

  • East Carolina University

    Greenville, North Carolina, 27834, United States

  • Endeavor Health (Northshore)

    Glenview, Illinois, 60026, United States

  • HCA - Trident Medical Center

    North Charleston, South Carolina, 29406, United States

  • HCA Florida Mercy Hospital

    Miami, Florida, 33133, United States

  • HCA Medical City Dallas

    Dallas, Texas, 75243, United States

  • HCA Medical City Fort Worth

    Fort Worth, Texas, 76104, United States

  • HCA Research Institute - Chippenham Hospital

    Richmond, Virginia, 23225, United States

  • HCA Research Institute Mission Hospital

    Asheville, North Carolina, 28801, United States

  • MercyOne Iowa Heart Center

    West Des Moines, Iowa, 50026, United States

  • Norton Heart & Vascular Institute

    Louisville, Kentucky, 40205, United States

  • OhioHealth Research Institute

    Columbus, Ohio, 43214, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239, United States

  • South Denver Cardiology Associates

    Littleton, Colorado, 80120, United States

  • St. Luke's Medical Center

    Boise, Idaho, 83712, United States

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124, United States

  • Sutter Health - California Pacific Medical Center

    San Francisco, California, 94109, United States

  • Texas Cardiac Arrhythmia Research Foundation (St. Davids)

    Austin, Texas, 78705, United States

  • The Arrythmia Center of South Florida

    Delray Beach, Florida, 33484, United States

  • The Christ Hospital - Heart & Vascular

    Cincinnati, Ohio, 45219, United States

  • The Heart Rhythm Center of Mississippi

    Gulfport, Mississippi, 39502, United States

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • WellSpan Health

    York, Pennsylvania, 17402, United States

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