Registry for patients treated with the PulseSelect™ PFA System for 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Epworth Richmond
  Richmond, Victoria, Australia Recruiting
• Auckland Hospital
  Auckland, New Zealand Recruiting
• Jessa Ziekenhuis
  Hasselt, Belgium Active not recruiting
• Vancouver General Hospital
  Vancouver, British Columbia, Canada Active not recruiting
• McGill University Health Centre (MUHC)
  Montreal, Quebec, Canada Active not recruiting
• Fuwai Hospital Chinese Academy of Medical Sciences
  Beijing, China Active not 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.