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Observational study on the PulseSelect PFA System for treating Atrial Fibrillation

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Observational Medtronic Cardiac Ablation Solutions · NCT06578104

This study is testing whether the PulseSelect PFA System can effectively treat people with recurring Atrial Fibrillation and how safe it is over three years.

Quick facts

Study typeObservational
Enrollment580 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Cardiac Ablation Solutions Industry-sponsored
Locations16 sites (Tampa, Florida and 15 other locations)
Trial IDNCT06578104 on ClinicalTrials.gov

What this trial studies

The PULSED AF Post-Approval Study is a global, multi-center, non-randomized observational trial that aims to evaluate the effectiveness of the PulseSelect™ PFA System in treating patients with recurrent symptomatic paroxysmal or persistent Atrial Fibrillation. Participants will undergo a pulmonary vein isolation procedure and will be monitored for 36 months with scheduled visits and Holter monitoring at specific intervals. This study will gather data on patient outcomes and the safety of the PulseSelect™ PFA System as part of standard care.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with recurrent symptomatic paroxysmal or persistent Atrial Fibrillation who have failed or are intolerant to at least one antiarrhythmic drug.

Not a fit: Patients with long-standing persistent Atrial Fibrillation, prior left atrial ablation, or those with a life expectancy of less than 36 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the PulseSelect™ PFA System for patients with Atrial Fibrillation.

How similar studies have performed: Other studies using similar ablation techniques have shown promising results, indicating potential for success in this observational study.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Tampa, Florida and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial Fibrillation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.