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New heart procedure tested for AFib control

NCT ID NCT06431815

Disease control Sponsor: Boston Scientific Corporation 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 5 times

Summary

This study looks at how safe and effective a new treatment called FARAPULSE pulsed field ablation is for people with a type of irregular heartbeat called paroxysmal atrial fibrillation. About 228 participants will be followed for up to 12 months to see if the procedure stops the heart rhythm problem without causing serious side effects. The goal is to control the condition, not cure it, as ongoing monitoring and possible medication may still be needed.

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

228 people

The number who actually took part.

Started

Sep 2024

Expected to finish

Oct 2029

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 with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a de-novo pulmonary vein isolation ablation with the FARAPULSE Pulsed Field Ablation (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: * Subjects with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF) who are indicated for a treatment with the FARAPULSE Pulsed Field Ablation (PFA) System\*; (Subjects refractory, or intolerant or contraindicated to at least one class I or III antiarrhythmic medication or contraindicated to any class I or III medications.) * Subjects who are willing and capable of providing informed consent; * Subjects who are willing and capable of participating in all testing and follow-up associated with this clinical study at an approved clinical investigational site; * Subjects who are of legal age to give informed consent specific to the national law. * For the LUX-Dx Sub-Study: Subjects with an existing LUX-Dx Insertable Cardiac Monitor (ICM), inserted ≥ 180 days prior to enrollment, or having a LUX-Dx ICM inserted per the investigator's standard of care, up to 7 days after the ablation procedure. Subjects with or having a LUX-Dx ICM inserted per standard of care, up to 7 days after the ablation procedure. Exclusion Criteria: * Subjects with any known contraindication to an AF ablation or anticoagulation, including those listed in the Instructions For Use (IFU); * Subjects with any prior left atrium (LA) ablation; * Subjects who may need an ablation in the left atrium besides PVI, such as for left-sided atrioventricular reentrant tachycardia (AVRT), left-sided atrial tachycardia (AT) or atypical left-sided atrial flutter (AFL); * Women of childbearing potential who are or plan to become pregnant during the time of the study (assessment per investigator's discretion); * Life expectancy of \< 1 year, per investigator's medical judgement.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation paroxysmal atrial fibrillation

As listed by the trial registrant

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

Paroxysmal atrial fibrillation

Contacts and locations

Locations

  • AdventHealth Tampa

    Tampa, Florida, 33613, United States

  • Alta Bates Summit Medical Center

    Oakland, California, 94609, United States

  • Baptist Medical Center

    Jacksonville, Florida, 32207, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Columbia University Medical Center

    New York, New York, 10019, United States

  • East Carolina University Medical Center

    Greenville, North Carolina, 27834, United States

  • Florida Heart Rhythm Specialists, PLLC

    Fort Lauderdale, Florida, 33308, United States

  • Hospital Regional de Concepcion

    Concepción, Biobio, 4070022, Chile

  • Institut de Cardiologie de Montreal-Hospital

    Montreal, Quebec, H1T 1C8, Canada

  • Institut universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec, G1V 4G5, Canada

  • Instituto do Coração do HCFMUSP

    São Paulo, São Paulo, 05403-900, Brazil

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36608, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • New York Hospital Queens

    Flushing, New York, 11355, United States

  • Northwell Health

    New York, New York, 10075, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Orion Medical

    Houston, Texas, 77034, United States

  • Pinnacle Health at Harrisburg Hospital

    Harrisburg, Pennsylvania, 17104, United States

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203, United States

  • Scottsdale Healthcare - Shea

    Scottsdale, Arizona, 85258, United States

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507, United States

  • Sos Cardio Servicoshospitalares Ltda

    Florianópolis, Santa Catarina, 88030-000, Brazil

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4504, United States

  • University of Texas Houston Health Science Center

    Houston, Texas, 77030, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0737, United States

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

More trials for these conditions

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