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Registry for patients treated with the PulseSelect™ PFA System for atrial fibrillation

PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform

Observational Medtronic Cardiac Ablation Solutions · NCT06393920

This study is tracking how well and safely the PulseSelect™ PFA System works for treating atrial fibrillation in a variety of patients over at least a year after their procedure.

Quick facts

Study typeObservational
Enrollment1950 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Cardiac Ablation Solutions Industry-sponsored
Locations28 sites (Vancouver, British Columbia and 27 other locations)
Trial IDNCT06393920 on ClinicalTrials.gov

What this trial studies

The PulseSelect™ PFA Global Registry is a prospective, multi-center, observational study designed to gather clinical performance and safety data from patients treated with the PulseSelect™ PFA System for atrial fibrillation. This post-market registry will follow subjects for a minimum of 12 months after their ablation procedure, which will be conducted according to standard hospital practices. The study aims to include a diverse patient population to assess the effectiveness and safety of the treatment in real-world settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with atrial fibrillation and are scheduled to undergo treatment with the PulseSelect™ PFA System.

Not a fit: Patients who are enrolled in other concurrent studies that do not allow for participation in this registry may not benefit from this study.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of the PulseSelect™ PFA System, potentially improving treatment options for patients with atrial fibrillation.

How similar studies have performed: Other studies involving observational registries for atrial fibrillation treatments have shown success in providing important data, making this approach a continuation of established methodologies.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Subject is ≥ 18 years of age or minimum age as required by local regulations.
* Subject has been diagnosed with atrial fibrillation (AF)
* Planned procedure using commercially available PulseSelect™ PFA System.
* Willing 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:

* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.
* Subject with exclusion criteria required by local law.

Where this trial is running

Vancouver, British Columbia and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial Fibrillation
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.