PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Kentucky
Pikeville Medical Center
RECRUITING
Whitesburg
Massachusetts
Southcoast Health System
RECRUITING
Fall River
Michigan
Beaumont Health System
RECRUITING
Royal Oak
Nebraska
Nebraska Medical Center
RECRUITING
Omaha
New York
Northwell Health Lenox Hill Hospital
RECRUITING
New York
The Valley Hospital
RECRUITING
New York
Ohio
Bethesda North Hospital
RECRUITING
Cincinnati
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Mount Carmel Grove City Medical Center
RECRUITING
Grove City
Pennsylvania
Doylestown Health Cardiology a division of Doylestown Health Physicians