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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 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 * 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
- PulseSelectâ„¢ PFA system (device)
Sponsor: Medtronic Cardiac Ablation Solutions · Participants: 580 · Started: Nov 4, 2024
Contact the study team
- Josman Suri · Phone: 7635050262
Official record on ClinicalTrials.gov — NCT06578104
Locations in the U.S.
| Florida | University of South Florida Health (USF), Tampa |
| Georgia | Piedmont Heart Institute, Atlanta |
| Illinois | Endeavor Health Swedish Hospital, Chicago |
| Kentucky | Pikeville Medical Center, Whitesburg |
| Massachusetts | Southcoast Health System, Fall River |
| Nebraska | Nebraska Medical Center, Omaha |
| New York | Northwell Health Lenox Hill Hospital, New York The Valley Hospital, New York |
| North Carolina | Duke University Medical Center (DUMC), Durham |
| Ohio | Bethesda North Hospital, Cincinnati Mount Carmel Grove City Medical Center, Grove City |
| Pennsylvania | Doylestown Health Cardiology a division of Doylestown Health Physicians, Doylestown |
| South Carolina | AnMed Health Center, Anderson Medical University of South Carolina (MUSC), Charleston |
| Virginia | University of Virginia Medical Center, Charlottesville |
| Washington | Confluence 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.