PULSED AF Post-Approval Study

Recruiting now

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06578104

Run by

Medtronic Cardiac Ablation Solutions

People needed

580

Starts

2024-11-04

Expected to finish

2030-04-30

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• University of Virginia Medical Center — Charlottesville, Virginia, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Endeavor Health Swedish Hospital — Chicago, Illinois, United States (enrolling)
• Pikeville Medical Center — Whitesburg, Kentucky, United States (enrolling)
• Southcoast Health System — Fall River, Massachusetts, United States (enrolling)
• University of South Florida Health (USF) — Tampa, Florida, United States (enrolling)
• Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• The Valley Hospital — New York, New York, United States (enrolling)
• Northwell Health Lenox Hill Hospital — New York, New York, United States (enrolling)
• Duke University Medical Center (DUMC) — Durham, North Carolina, United States (enrolling)
• Bethesda North Hospital — Cincinnati, Ohio, United States (enrolling)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Mount Carmel Grove City Medical Center — Grove City, Ohio, United States (enrolling)
• Doylestown Health Cardiology a division of Doylestown Health Physicians — Doylestown, Pennsylvania, United States (enrolling)
• AnMed Health Center — Anderson, South Carolina, United States (enrolling)
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (enrolling)
• Texas Health Research & Education Institute — Dallas, Texas, United States (enrolling)
• Beaumont Health System — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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