PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry
Medtronic Cardiac Ablation Solutions
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.
Description
PulseSelect is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months. Study visits will occur at 3, 6, 12, 24, and 36 months post-ablation, including required 24-hour Holter monitoring at 6, 12, 24, and 36 month visits. The PulseSelect™ PFA System used in this study is market approved and the ablation procedure will be performed according to hospital standard of care.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 req…
Interventions
- DevicePulseSelect™ PFA system
Ablation using the PulseSelect™ PFA system
Locations (16)
- University of South Florida Health (USF)Tampa, Florida
- Pikeville Medical CenterWhitesburg, Kentucky
- Southcoast Health SystemFall River, Massachusetts
- Beaumont Health SystemRoyal Oak, Michigan
- Nebraska Medical CenterOmaha, Nebraska
- The Valley HospitalNew York, New York