Actively Recruiting
PULSED AF Post-Approval Study
Led by Medtronic Cardiac Ablation Solutions · Updated on 2026-03-27
580
Participants Needed
16
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PULSED AF Post-Approval Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent symptomatic paroxysmal or persistent atrial fibrillation
- Refractory to at least one Class I or III antiarrhythmic drug (not effective, not tolerated, or not desired)
- Age 18 years or older
- Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System
- Willing and able to comply with study requirements and provide informed consent or authorization per local rules
You will not qualify if you...
- Long-standing persistent atrial fibrillation (continuous for more than 12 months)
- Prior left atrial catheter or surgical ablation
- Life expectancy less than 36 months
- Presence of permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor, or any implantable cardiac defibrillator
- Current or planned participation in other clinical trials of unapproved drugs, devices, or biologics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University of South Florida Health (USF)
Tampa, Florida, United States, 33606-3603
Actively Recruiting
2
Pikeville Medical Center
Whitesburg, Kentucky, United States, 41858-7428
Actively Recruiting
3
Southcoast Health System
Fall River, Massachusetts, United States, 02720
Actively Recruiting
4
Beaumont Health System
Royal Oak, Michigan, United States, 48073
Withdrawn
5
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
6
The Valley Hospital
New York, New York, United States, 10025
Actively Recruiting
7
Northwell Health Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
8
Duke University Medical Center (DUMC)
Durham, North Carolina, United States, 27710
Actively Recruiting
9
Bethesda North Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
10
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 045218
Actively Recruiting
11
Mount Carmel Grove City Medical Center
Grove City, Ohio, United States, 43123
Actively Recruiting
12
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown, Pennsylvania, United States, 18901-2554
Actively Recruiting
13
AnMed Health Center
Anderson, South Carolina, United States, 29621
Actively Recruiting
14
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425-8908
Actively Recruiting
15
Texas Health Research & Education Institute
Dallas, Texas, United States, 75231-3815
Actively Recruiting
16
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
J
Josman Suri
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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