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RecruitingNCT06578104Updated Sep 22, 2026

PULSED AF Post-Approval Study

An observational study in Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions. Recruiting at 23 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Medtronic Cardiac Ablation Solutions · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
580
Ages
18 Years and older
Sex
All
01

Study summary

PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Read the detailed description

PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.

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Conditions studied

  • Atrial Fibrillation

Browse trials for

03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 580 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Medtronic Cardiac Ablation Solutions is the lead sponsor of 37 studies on the registry; 10 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
580 participants (estimated)
Patient registry
No

Groups and cohorts

  • Paroxysmal

    Ablation using the PulseSelect™ PFA system

    Device: PulseSelect™ PFA system

  • Persistent

    Ablation using the PulseSelect™ PFA system

    Device: PulseSelect™ PFA system

Interventions

  • DevicePulseSelect™ PFA system

    Ablation using the PulseSelect™ PFA system

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What researchers measure

Primary outcomes

  1. Efficacy-Freedom from Atrial Fibrillation

    Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.

    Time frame: 36-months after the index ablation procedure

  2. Safety- Freedom from Device/Procedure Related Adverse Events

    Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.

    Time frame: 6 months post-ablation]

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Study locations

20 of 23 sites recruiting
  • University of South Florida Health (USF)
    Tampa, Florida 33606-3603, United States
    Recruiting
  • Piedmont Heart Institute
    Atlanta, Georgia 30309, United States
    Recruiting
  • Endeavor Health Swedish Hospital
    Chicago, Illinois 60625, United States
    Recruiting
  • Pikeville Medical Center
    Whitesburg, Kentucky 41858-7428, United States
    Recruiting
  • Southcoast Health System
    Fall River, Massachusetts 02720, United States
    Recruiting
  • Beaumont Health System
    Royal Oak, Michigan 48073, United States
    Withdrawn
  • Nebraska Medical Center
    Omaha, Nebraska 68198, United States
    Recruiting
  • The Valley Hospital
    New York, New York 10025, United States
    Recruiting
  • Northwell Health Lenox Hill Hospital
    New York, New York 10075, United States
    Recruiting
  • Duke University Medical Center (DUMC)
    Durham, North Carolina 27710, United States
    • Kevin Jackson · Contact · (919) 684-8111
    Recruiting
  • Bethesda North Hospital
    Cincinnati, Ohio 45220, United States
    Recruiting
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 045218, United States
    Terminated
  • Mount Carmel Grove City Medical Center
    Grove City, Ohio 43123, United States
    Recruiting
  • Doylestown Health Cardiology a division of Doylestown Health Physicians
    Doylestown, Pennsylvania 18901-2554, United States
    Recruiting
  • AnMed Health Center
    Anderson, South Carolina 29621, United States
    Recruiting
  • Medical University of South Carolina (MUSC)
    Charleston, South Carolina 29425-8908, United States
    Recruiting
  • Texas Health Research & Education Institute
    Dallas, Texas 75231-3815, United States
    Active, not recruiting
  • University of Virginia Medical Center
    Charlottesville, Virginia 22908, United States
    Recruiting
  • Confluence Health Hospital Central Campus
    Wenatchee, Washington 98801, United States
    Recruiting
  • London Health Sciences Centre - University Campus
    London, Ontario N6A 5A5, Canada
    Recruiting
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario, Canada
    Recruiting
  • Montreal Heart Institute
    Montreal, Quebec H1T 1C8, Canada
    Recruiting
  • Keimyung University Dongsan Hospital
    Daegu, 42601, South Korea
    • Hyoung Seob Park, MD · Contact · drparkgyver@gmail.com · +82 532507407
    • Hyoung Seob Park, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06578104
Lead sponsor
Medtronic Cardiac Ablation Solutions
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Nov 4, 2024
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Sep 22, 2026

Study contacts

Josman Suri
Contact
josman.suri@medtronic.com
7635050262
Khaldoun Tarakji, MD
study director · Medtronic CAS Chief Medical Officer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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