PULSED AF (Atrial Fibrillation)

Purpose of this Study

We are doing this study to collect information about the clinical performance of the PulseSelect® Pulsed Field Ablation (PFA) System. The PFA system was recently approved by the FDA as a treatment for both paroxysmal and persistent atrial fibrillation (AF). We want to learn more about how well it works for AF patients now that it is a widely available option. We will assess how well it improves symptoms for people who who have persistent AF that has lasted less than one year, or have experienced episodes of paroxysmal atrial fibrillation, or have persistent or paroxysmal atrial fibrillation that is not controlled by medication, or have symptoms from their persistent or paroxysmal atrial fibrillation.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with recurrent symptomatic paroxysmal AF or persistent AF
  • Cannot be treated with at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)
  • Are planning to have a pulmonary vein isolation procedure with the PulseSelect® PFA System
For more information, contact the study team at jessalyn.crews@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, the study doctor and study coordinator will collect information about you and your medical history, including medications that you are currently taking or recently used. You will be considered enrolled in the study once you sign the consent form before your planned procedure. None of the procedures in this study are experimental. You will visit the study team at the following times during the study:
  • On the day of enrollment when you sign the study's consent form
  • The day of your ablation procedure
  • 3 months after your ablation procedure
  • 6 months after your ablation procedure
  • 1 year after your ablation procedure
  • 2 years after your ablation procedure
  • 3 years after your ablation procedure
The 6 month and the 1 year follow-up visits will need to be in our clinic, but the rest of the visits can be done remotely (over the phone).

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

Study Details

Full Title

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Principal Investigator

Kevin
Jackson

Protocol Number

PRO00117351

NCT ID

NCT06578104

Phase

IV

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov