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Observational Study of Farapulse PFA for Atrial Fibrillation

This study, called the DISRUPT-AF Registry, is looking at how well and how safely the Farapulse Pulsed Field Ablation System works for people with atrial fibrillation (AF), a condition where your heart beats irregularly. It's an observational study, meaning researchers will watch what happens to patients who are already receiving this treatment in real-world settings. You might be able to join if your doctor thinks you're a good candidate for AF ablation and plans to use the Farapulse system. The study aims to understand the long-term effectiveness and safety of this treatment over 12 months. This study is currently enrolling a large number of participants, with a goal of 10,000 people.

Study design
This is an observational, multi-center, non-randomized study aiming to enroll 10,000 participants.
What's involved
Depending on the study arm, you would have assessments before your procedure, during the procedure, and at 3 months and 1 year after ablation. Some arms also include assessments for asymptomatic recurrence at 6 and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for long-term effectiveness and safety for 12 months after their ablation procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06335082

A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF

Enrolling by Invitation
Not specifiedAges 18+Observational
Heart Rhythm Clinical and Research Solutions, LLC
~10,000 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Pulsed Field Ablation

At a glance

Recruiting sites
0 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Long term effectiveness
Measured over 12 months
+1 more outcome measured

Conditions

Atrial Fibrillation

Explore related trials

Atrial FibrillationLongstanding persistent atrial fibrillationParoxysmal Atrial FibrillationPersistent atrial fibrillation

NCT06335082

Where you'd take part

This study runs at 36 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Allegheny General Hospital

    Pittsburgh, Pennsylvaniano site contact published

  • Arrhythmia Institute at Grandview

    Birmingham, Alabamano site contact published

  • Arrhythmia Research Group

    Jonesboro, Arkansasno site contact published

  • Ascension St Vincent -Indianapolis Ascension Health

    Indianapolis, Indianano site contact published

  • Ascension St. Thomas Nashville

    Nashville, Tennesseeno site contact published

  • Ascension St. Vincent's

    Jacksonville, Floridano site contact published

  • Ascension Texas Cardiovascular

    Austin, Texasno site contact published

  • Brigham and Women's Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Long term effectiveness12 months

    Freedom from atrial arrhythmia recurrence post 90-day blanking period

  • Long-term safety12 months

    Rate of long-term safety events defined as procedure or device related reportable events (complications) that occur greater than 30 days post ablation. Data for this endpoint will be evaluated from the pooled results of the SMO and FM study arms.