Clinical Trials in South Korea / NCT06578104
Recruiting
Observational
PULSED AF Post-Approval Study
NCT06578104 · tracked via the Priya Life Science South Korea tracker
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
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)
- Efficacy-Freedom from Atrial Fibrillation — 36-months after the index ablation procedure
Estimate the 36-month freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system. - Safety- Freedom from Device/Procedure Related Adverse Events — 6 months post-ablation]
Estimate the rate of major procedural complications for catheter ablation using PulseSelect™ PFA system.
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 | Terminated |
| 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 South Korea
PulseSelect™ PFA Global Registry
Recruiting
Other trials for the same condition
Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)
Active, not recruiting
Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF
Starting soon
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 South Korea