Follows people with atrial fibrillation treated with the PulseSelect pulsed field ablation system
Follows adults with atrial fibrillation treated with the PulseSelect device over 36 months.
Plain-language title generated from the registry record
Registry title: PULSED AF Post-Approval Study
Key facts
- Where
- Anderson, Atlanta, Charleston, Charlottesville, Chicago, Cincinnati, Columbus, Dallas, Doylestown, Durham, Fall River, Grove City, New York, Omaha, Royal Oak, Tampa, Wenatchee, and Whitesburg, United StatesSee the 19 sites
Where in United States
- AnMed Health CenterAnderson, United StatesTaking people
- Piedmont Heart InstituteAtlanta, United StatesTaking people
- Medical University of South Carolina (MUSC)Charleston, United StatesTaking people
- University of Virginia Medical CenterCharlottesville, United StatesTaking people
- Endeavor Health - Swedish HospitalChicago, United StatesTaking people
- Bethesda North HospitalCincinnati, United StatesTaking people
- The Ohio State University -Wexner Medical CenterColumbus, United StatesNo longer taking part
- Texas Health Research & Education InstituteDallas, United StatesNo longer taking part
- Doylestown Health Cardiology a division of Doylestown Health PhysiciansDoylestown, United StatesTaking people
- Duke University Medical Center (DUMC)Durham, United StatesTaking people
- Southcoast Health SystemFall River, United StatesTaking people
- Mount Carmel Grove City Medical CenterGrove City, United StatesTaking people
- Northwell Health- Lenox Hill HospitalNew York, United StatesTaking people
- The Valley HospitalNew York, United StatesTaking people
- Nebraska Medical CenterOmaha, United StatesTaking people
- Beaumont Health SystemRoyal Oak, United StatesNo longer taking part
- University of South Florida Health (USF)Tampa, United StatesNo longer taking part
- Confluence Health Hospital Central CampusWenatchee, United StatesTaking people
- Pikeville Medical CenterWhitesburg, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic Cardiac Ablation Solutions
- Trial code
- NCT06578104
- Record updated
- 28 October 2026
- Original description
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 full original descriptionShow less
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
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.
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: Prior left atrial catheter or surgical ablation; Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager; 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); Long-standing persistent AF (continuous AF sustained >12 months); Patient with life expectancy < 36 months.