PULSED AF Post-Approval Study
Recruiting now NCT06578104
Run by Medtronic Cardiac Ablation Solutions · for 18 and older · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- 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
🚫 You may not be able to join if…
- 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
Where this trial is running
- University of South Florida Health (USF), Tampa, Florida, United States
- Piedmont Heart Institute, Atlanta, Georgia, United States
- Endeavor Health Swedish Hospital, Chicago, Illinois, United States
- Pikeville Medical Center, Whitesburg, Kentucky, United States
- Southcoast Health System, Fall River, Massachusetts, United States
- Beaumont Health System, Royal Oak, Michigan, United States
- Nebraska Medical Center, Omaha, Nebraska, United States
- The Valley Hospital, New York, New York, United States
- Northwell Health Lenox Hill Hospital, New York, New York, United States
- Duke University Medical Center (DUMC), Durham, North Carolina, United States
- Bethesda North Hospital, Cincinnati, Ohio, United States
- The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
+ 11 more sites.
Who to contact
Josman Suri · 7635050262 · josman.suri@medtronic.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06578104.
Verify everything on the official ClinicalTrials.gov record. Page updated September 2026.
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