PULSED AF Post-Approval Study
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Cardiac Ablation Solutions
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PulseSelect™ PFA system
DeviceAblation using the PulseSelect™ PFA system
Treatment groups
580 Participants
are divided into 2 treatment groupsGroup A: Paroxysmal1 intervention
Group B: Persistent1 intervention
Trial outcomes
Primary outcomes
1
Efficacy-Freedom from Atrial Fibrillation
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
Time frame
36-months after the index ablation procedure2
Safety- Freedom from Device/Procedure Related Adverse Events
Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.
Time frame
6 months post-ablation]Sponsors and contacts
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Source ClinicalTrials.gov