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PULSED AF Post-Approval Study

Sponsored by Medtronic Cardiac Ablation Solutions

About this study

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.

PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.

Where this study is enrolling (16)

Show all 16 locations

  • Nebraska Medical Center

    Omaha, Nebraska

    I'm interested

  • The Valley Hospital

    New York, New York

    I'm interested

  • Northwell Health Lenox Hill Hospital

    New York, New York

    I'm interested

  • Duke University Medical Center (DUMC)

    Durham, North Carolina

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  • Mount Carmel Grove City Medical Center

    Grove City, Ohio

    I'm interested

  • Bethesda North Hospital

    Cincinnati, Ohio

    I'm interested

  • Doylestown Health Cardiology a division of Doylestown Health Physicians

    Doylestown, Pennsylvania

    I'm interested

  • AnMed Health Center

    Anderson, South Carolina

    I'm interested

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina

    I'm interested

  • University of Virginia Medical Center

    Charlottesville, Virginia

    I'm interested

  • Confluence Health Hospital Central Campus

    Wenatchee, Washington

    I'm interested
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.