COVID-19 Vaccine: Valley's Wellness and Walk-In Care Center at Garden State Plaza is offering the COVID-19 vaccine, including initial and booster doses, for those who are eligible. Learn more and schedule an appointment.
COVID-19 Vaccine: Valley's Wellness and Walk-In Care Center at Garden State Plaza is offering the COVID-19 vaccine, including initial and booster doses, for those who are eligible. Learn more and schedule an appointment.
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported.
1. Failure of at least one AAD (class I or III) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
2. A diagnosis of recurrent symptomatic paroxysmal or persistent AF:
3. Age 18 through 80 years old (or older than 18 if required by local law)
NCT04198701