PULSED - AF

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

Objective

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.

Study Arms

• Experimental: Pilot
• Experimental: Pivotal - Roll-In
• Experimental: Pivotal - Paroxysmal AF
• Experimental: Pivotal - Persistent AF

Eligibility

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:

• Symptomatic paroxysmal AF, which is defined as AF that terminates spontaneously or with intervention within 7 days of onset, documented by the following:
  • physician's note indicating at least 2 symptomatic paroxysmal AF episodes occurring within 6 months prior to enrollment; and
  • at least 1 ECG documented AF episode from any form of rhythm monitoring within 12 months prior to enrollment OR
• Symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year, documented by the following:
  • physician's note indicating at least 1 symptomatic persistent AF episode occurring within 6 months prior to enrollment; and
  • any 24-hour continuous ECG recording documenting continuous AF within 6 months prior to enrollment; OR 2 ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment

3. Age 18 through 80 years old (or older than 18 if required by local law)

NCT ID

NCT04198701