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PULSED AF Post-Approval Study for Atrial Fibrillation

This study is looking at how well the PulseSelect™ PFA system works for people with atrial fibrillation (AF), a type of irregular heartbeat. You might be able to join if you are 18 or older, have symptomatic AF that hasn't responded to other medications, and are planning to have a procedure called pulmonary vein isolation using the PulseSelect™ PFA system. The main goals are to see how many people are free from AF 36 months after the procedure and to track any device or procedure-related problems for 6 months. The current recruitment status is unclear.

Study design
This is an observational study that will follow 580 participants globally. It is not randomized, meaning participants are not assigned to different treatment groups by chance.
What's involved
You would have study visits at 3, 6, 12, 24, and 36 months after your ablation procedure. These visits include required 24-hour Holter monitoring at 6, 12, 24, and 36 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 36 months after their ablation procedure to assess the effectiveness of the treatment.

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

NCT06578104

PULSED AF Post-Approval Study

Recruiting
Not specifiedAges 18+Observational
Medtronic Cardiac Ablation Solutions
~580 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:PulseSelect™ PFA system

At a glance

Recruiting sites
20 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy-Freedom from Atrial Fibrillation
Measured over 36-months after the index ablation procedure
+1 more outcome measured

Conditions

Atrial Fibrillation

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Atrial Fibrillation

NCT06578104

Where you'd take part

This study runs at 23 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • AnMed Health Center

    Anderson, South Carolinastudy coordinator listed

    Recruiting

  • Bethesda North Hospital

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • Confluence Health Hospital Central Campus

    Wenatchee, Washingtonstudy coordinator listed

    Recruiting

  • Doylestown Health Cardiology a division of Doylestown Health Physicians

    Doylestown, Pennsylvaniastudy coordinator listed

    Recruiting

  • Duke University Medical Center (DUMC)

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Endeavor Health Swedish Hospital

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, South Koreastudy coordinator listed

    Recruiting

  • London Health Sciences Centre - University Campus

    London, Ontario, Canadastudy coordinator listed

    Recruiting

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

Study leadership

  • Khaldoun Tarakji, MD · STUDY_DIRECTOR · Medtronic CAS Chief Medical Officer

Who to contact

Josman Suri
[email protected]
7635050262
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Efficacy-Freedom from Atrial Fibrillation36-months after the index ablation procedure

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

  • Safety- Freedom from Device/Procedure Related Adverse Events6 months post-ablation]

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