Taking people in CanadaNo phase
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.
Key facts
- Who runs it
- Medtronic Cardiac Ablation Solutions
- Where
- London, Montreal, Québec, Toronto, and Vancouver, CanadaSee the 6 sitesAlso in 2 other countries, 23 sites
- Trial code
- Registry title
- PULSED AF Post-Approval Study
- Status
- Recruiting
- People taking part
- 580 people, planned
- Started
- 4 Nov 2024
- Expected to end
- 30 Apr 2030
- Type of study
- Observational, 2 groups
- Treatments tested
- PulseSelect™ PFA system
- Record updated
- 12 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation that keeps coming back or is persistent, who did not do well on at least one rhythm drug. They plan to have a pulmonary vein isolation procedure with the PulseSelect PFA System.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Recurrent symptomatic paroxysmal atrial fibrillation (AF) or persistent AF. Long-standing persistent AF (continuous AF for more than 12 months) is excluded.
- Earlier treatment
- Must not have worked, been tolerated or been wanted with at least one Class I or III antiarrhythmic drug. Must not have had a left atrial catheter or surgical ablation before.
Main reasons for not taking part
- Long-standing persistent AF (continuous AF for more than 12 months)
- Earlier left atrial catheter or surgical ablation
- Life expectancy under 36 months
- A permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor, or any implantable cardiac defibrillator
- Taking part in another drug, device or biologic trial not approved by the global study manager
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Canada
Also in 2 other countries, 23 sites
- London Health Sciences Centre- University CampusLondon, CanadaContact: Habib KhanTaking people
- Montreal Heart InstituteMontreal, CanadaContact: Katia Dyrda, MDTaking people
- Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)Québec, CanadaContact: Karine Roy, MDTaking people
- Saint Michaels Hospital (Toronto)Toronto, CanadaContact: Paul Angaran, MDTaking people
- Sunnybrook Health Sciences CentreToronto, CanadaContact: Sheldon SinghTaking people
- Vancouver General HospitalVancouver, CanadaContact: Jason Andrade, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Paroxysmal
Ablation using the PulseSelect™ PFA system
Treatment: PulseSelect™ PFA system
- Persistent
Ablation using the PulseSelect™ PFA system
Treatment: PulseSelect™ PFA system
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
- Plain-language title
- Follows people with atrial fibrillation treated with the PulseSelect pulsed field ablation systemGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 November 2026