Follows people with atrial fibrillation treated with the PulseSelect pulsed field ablation system
Follows adults with atrial fibrillation treated with the PulseSelect device over 36 months.
Plain-language title generated from the registry record
Registry title: PULSED AF Post-Approval Study
Key facts
- Where
- London, Montreal, and Toronto, CanadaSee the 3 sites
Where in Canada
- London Health Sciences Centre- University CampusLondon, CanadaTaking people
- Montreal Heart InstituteMontreal, CanadaTaking people
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medtronic Cardiac Ablation Solutions
- Trial code
- NCT06578104
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
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.
Inclusion: 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: Prior left atrial catheter or surgical ablation; Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager; 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); Long-standing persistent AF (continuous AF sustained >12 months); Patient with life expectancy < 36 months.