Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: PulseSelect™ PFA system for Atrial Fibrillation

PULSED AF PAS is a prospective, global, multi-center, non-randomly assigned, watch-and-measure (no experimental treatment required) trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.

Official registry: https://clinicaltrials.gov/study/NCT06578104 · Medtronic Cardiac Ablation Solutions · enrollment listed as 580

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 580 people at 23 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

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

Interventions: PulseSelect™ PFA system

Primary outcome (registry wording): Efficacy-Freedom from Atrial Fibrillation

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Josman Suri

7635050262

josman.suri@medtronic.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

23 listed

+ 4 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingPhase 3Phoenix, Arizona
Phase 3: testing Continuous DOAC therapy for Atrial Fibrillation

REACT-AF is a multicenter prospective, randomly assigned, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

NCT05836987 · Official ClinicalTrials.gov record · Johns Hopkins University

FAQ about this NCT record

Is NCT06578104 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06578104?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06578104?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary