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Clinical Trials in the USA / NCT06578104
Recruiting Observational

PULSED AF Post-Approval Study

NCT06578104 · tracked via the Priya Life Science USA tracker
Sponsor
Medtronic Cardiac Ablation Solutions
Phase
Observational
Started
2024-11-04
Last updated
2026-08-12

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

PulseSelect™ PFA system

PulseSelect™ PFA system: Ablation using the PulseSelect™ PFA system

Study summary

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
University of South Florida Health (USF) Tampa Florida Recruiting
Piedmont Heart Institute Atlanta Georgia Recruiting
Endeavor Health Swedish Hospital Chicago Illinois Recruiting
Pikeville Medical Center Whitesburg Kentucky Recruiting
Southcoast Health System Fall River Massachusetts Recruiting
Beaumont Health System Royal Oak Michigan Withdrawn
Nebraska Medical Center Omaha Nebraska Recruiting
The Valley Hospital New York New York Recruiting
Northwell Health Lenox Hill Hospital New York New York Recruiting
Duke University Medical Center (DUMC) Durham North Carolina Recruiting
Bethesda North Hospital Cincinnati Ohio Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Active Not Recruiting
Mount Carmel Grove City Medical Center Grove City Ohio Recruiting
Doylestown Health Cardiology a division of Doylestown Health Physicians Doylestown Pennsylvania Recruiting
AnMed Health Center Anderson South Carolina Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina Recruiting
Texas Health Research & Education Institute Dallas Texas Active Not Recruiting
University of Virginia Medical Center Charlottesville Virginia Recruiting
Confluence Health Hospital Central Campus Wenatchee Washington Recruiting
London Health Sciences Centre - University Campus London Ontario Recruiting
Sunnybrook Health Sciences Centre Toronto Ontario Recruiting
Montreal Heart Institute Montreal Quebec Recruiting
Keimyung University Dongsan Hospital Daegu South Korea Recruiting

More Medtronic Cardiac Ablation Solutions trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06578104 on ClinicalTrials.gov ↗ ← All trials in the USA