PULSED AF Post-Approval Study
1 other identifier
observational
580
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2024
CompletedFirst Posted
Study publicly available on registry
August 29, 2024
CompletedStudy Start
First participant enrolled
November 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
March 27, 2026
February 1, 2026
1.6 years
August 27, 2024
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy-Freedom from Atrial Fibrillation
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.
36-months after the index ablation procedure
Safety- Freedom from Device/Procedure Related Adverse Events
Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.
6 months post-ablation]
Study Arms (2)
Paroxysmal
Ablation using the PulseSelect™ PFA system
Persistent
Ablation using the PulseSelect™ PFA system
Interventions
Eligibility Criteria
Subjects 18 years or older with a planned procedure using commercially available PulseSelect™ PFA System
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of South Florida Health (USF)
Tampa, Florida, 33606-3603, United States
Pikeville Medical Center
Whitesburg, Kentucky, 41858-7428, United States
Southcoast Health System
Fall River, Massachusetts, 02720, United States
Beaumont Health System
Royal Oak, Michigan, 48073, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
The Valley Hospital
New York, New York, 10025, United States
Northwell Health Lenox Hill Hospital
New York, New York, 10075, United States
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710, United States
Bethesda North Hospital
Cincinnati, Ohio, 45220, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 045218, United States
Mount Carmel Grove City Medical Center
Grove City, Ohio, 43123, United States
Doylestown Health Cardiology a division of Doylestown Health Physicians
Doylestown, Pennsylvania, 18901-2554, United States
AnMed Health Center
Anderson, South Carolina, 29621, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425-8908, United States
Texas Health Research & Education Institute
Dallas, Texas, 75231-3815, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Khaldoun Tarakji, MD
Medtronic CAS Chief Medical Officer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2024
First Posted
August 29, 2024
Study Start
November 4, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2029
Last Updated
March 27, 2026
Record last verified: 2026-02