PULSED AF Post-Approval Study
Recruiting · NCT06578104 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medtronic Cardiac Ablation Solutions
View the official record on ClinicalTrials.gov →Interventions studied
PulseSelect™ PFA system
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
23 locations listed across 15 US states.
- University of South Florida Health (USF) - Tampa, Florida, United States
- Piedmont Heart Institute - Atlanta, Georgia, United States
- Endeavor Health Swedish Hospital - Chicago, Illinois, United States
- Pikeville Medical Center - Whitesburg, Kentucky, United States
- Southcoast Health System - Fall River, Massachusetts, United States
- Beaumont Health System - Royal Oak, Michigan, United States
- Nebraska Medical Center - Omaha, Nebraska, United States
- The Valley Hospital - New York, New York, United States
- Northwell Health Lenox Hill Hospital - New York, New York, United States
- Duke University Medical Center (DUMC) - Durham, North Carolina, United States
- Bethesda North Hospital - Cincinnati, Ohio, United States
- The Ohio State University Wexner Medical Center - Columbus, Ohio, United States
- Mount Carmel Grove City Medical Center - Grove City, Ohio, United States
- Doylestown Health Cardiology a division of Doylestown Health Physicians - Doylestown, Pennsylvania, United States
- AnMed Health Center - Anderson, South Carolina, United States
- Medical University of South Carolina (MUSC) - Charleston, South Carolina, United States
- Texas Health Research & Education Institute - Dallas, Texas, United States
- University of Virginia Medical Center - Charlottesville, Virginia, United States
- Confluence Health Hospital Central Campus - Wenatchee, Washington, United States
- Keimyung University Dongsan Hospital - Daegu, South Korea
- London Health Sciences Centre - University Campus - London, Ontario, Canada
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada
- Montreal Heart Institute - Montreal, Quebec, Canada