NCT06578104Recruiting
PULSED AF Post-Approval Study
PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 580 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- 4 Nov 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Diseases
- Atrial fibrillation
- NCT number
- NCT06578104
What you commit to
- Study type: Observational
- Planned participants: 580
- From 4 Nov 2024 to the primary completion date, 30 Apr 2027
- 23 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior left atrial catheter or surgical ablation
- Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager
Other illness
- 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)
Other
- Long-standing persistent AF (continuous AF sustained \>12 months)
- Patient with life expectancy \< 36 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Centre- University Campus Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| AnMed Health Center Coordinator of this site? Confirm its status | Anderson | United States | Recruiting |
| Piedmont Heart Institute Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Medical University of South Carolina (MUSC) Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Virginia Medical Center Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Endeavor Health - Swedish Hospital Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Bethesda North Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| The Ohio State University -Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Terminated |
| Texas Health Research & Education Institute Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| Doylestown Health Cardiology a division of Doylestown Health Physicians Coordinator of this site? Confirm its status | Doylestown | United States | Recruiting |
| Duke University Medical Center (DUMC) Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Southcoast Health System Coordinator of this site? Confirm its status | Fall River | United States | Recruiting |
| Mount Carmel Grove City Medical Center Coordinator of this site? Confirm its status | Grove City | United States | Recruiting |
| The Valley Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Northwell Health- Lenox Hill Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Beaumont Health System Coordinator of this site? Confirm its status | Royal Oak | United States | Withdrawn |
| University of South Florida Health (USF) Coordinator of this site? Confirm its status | Tampa | United States | Terminated |
| Confluence Health Hospital Central Campus Coordinator of this site? Confirm its status | Wenatchee | United States | Recruiting |
| Pikeville Medical Center Coordinator of this site? Confirm its status | Whitesburg | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.