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NCT Number: NCT06393920

PulseSelect™ PFA Global Registry

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

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About this study

The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to collect clinical performance and safety data in a broad patient population treated with the PulseSelect™ PFA system. The PulseSelect™ PFA System used in the study is market approved. The ablation procedure will be performed according to routine hospital practice. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Efficacy-Freedom from Atrial Fibrillation

    Time frame: ≥ 91 days after the index ablation procedure

    Estimate the freedom from AF/AFL/AT recurrence following ablation using the PulseSelect™ PFA system.

  2. Safety- Freedom from Device/Procedure Related Adverse Events

    Time frame: Within 6 months post-ablation

    Estimate serious device and serious procedure-related adverse events for the PulseSelect™ PFA system

Study contacts

Contact information is provided by the study sponsor or research team.

Josman Suri

CONTACT

[email protected]

7635050262

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Ablation Solutions

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 1, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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