Observational study on the PulseSelect PFA System for treating Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PULSED AF Post-Approval Study is a global, multi-center, non-randomized observational trial that aims to evaluate the effectiveness of the PulseSelect™ PFA System in treating patients with recurrent symptomatic paroxysmal or persistent Atrial Fibrillation. Participants will undergo a pulmonary vein isolation procedure and will be monitored for 36 months with scheduled visits and Holter monitoring at specific intervals. This study will gather data on patient outcomes and the safety of the PulseSelect™ PFA System as part of standard care.

Why it matters

Who can join: the full rules

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 requirements

Exclusion Criteria

* Long-standing persistent AF (continuous AF sustained \>12 months)
* Prior left atrial catheter or surgical ablation
* Patient with life expectancy \< 36 months
* 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)
* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager

Where it's running

• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Endeavor Health Swedish Hospital
  Chicago, Illinois, United States Recruiting
• Pikeville Medical Center
  Whitesburg, Kentucky, United States Recruiting
• Southcoast Health System
  Fall River, Massachusetts, United States Recruiting
• Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting
• The Valley Hospital
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Josman Suri
• Email: josman.suri@medtronic.com
• Phone: 7635050262

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.