A Study to Evaluate Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat Atrial Fibrillation (AF)

Overview

About this study

The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelectTM PFA System for the treatment of paroxysmal and persistent atrial fibrillation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Failure of at least one AAD (class I orIII) for AF as evidenced by recurrent symptomatic AF, or intolerable side effects due to AAD.
  • 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
  • ECGs from any form of rhythm monitoring taken at least 7 days apart, both showing continuous AF within 6 months prior to enrollment.
  • Age 18 through 80 years old (or older than 18 if required by local law).

Exclusion Criteria:

  • Long-standing persistent AF (continuous AF that is sustained >12 months).
  • Left atrial diameter > 5.0 cm (anteroposterior).
  • Prior left atrial ablation or surgical procedure (including left atrial appendage closures).
  • Planned LAA closure procedure or implant 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) for any time during the follow-up period.
  • Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure.
  • 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).
  • Presence of any pulmonary vein stents.
  • Presence of any pre-existing pulmonary vein stenosis.
  • Pre-existing hemidiaphragmatic paralysis.
  • Presence of any cardiac valve prosthesis

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Packer, M.D.

Open for enrollment

Contact information:

Heart Rhythm Services Research Office

(507) 255-7456

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available