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PULSED AF Post-Approval Study

RecruitingObservational study

PULSED AF Post-Approval Study, an Addendum to the PulseSelectâ„¢ PFA Global Registry

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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 PulseSelectâ„¢ 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

* 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

About the study

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

What is being tested

Sponsor: Medtronic Cardiac Ablation Solutions · Participants: 580 · Started: Nov 4, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06578104

Locations in the U.S.

FloridaUniversity of South Florida Health (USF), Tampa
GeorgiaPiedmont Heart Institute, Atlanta
IllinoisEndeavor Health Swedish Hospital, Chicago
KentuckyPikeville Medical Center, Whitesburg
MassachusettsSouthcoast Health System, Fall River
NebraskaNebraska Medical Center, Omaha
New YorkNorthwell Health Lenox Hill Hospital, New York
The Valley Hospital, New York
North CarolinaDuke University Medical Center (DUMC), Durham
OhioBethesda North Hospital, Cincinnati
Mount Carmel Grove City Medical Center, Grove City
PennsylvaniaDoylestown Health Cardiology a division of Doylestown Health Physicians, Doylestown
South CarolinaAnMed Health Center, Anderson
Medical University of South Carolina (MUSC), Charleston
VirginiaUniversity of Virginia Medical Center, Charlottesville
WashingtonConfluence Health Hospital Central Campus, Wenatchee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.