PulseSelect™ PFA Global Registry

Last updated: April 28, 2025
Sponsor: Medtronic Cardiac Ablation Solutions
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Dysrhythmia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT06393920
PulseSelect™ PFA Registry
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 aslegally effective, documented confirmation of a subject's voluntary agreement toparticipate in this clinical study) or authorization per institution andgeographical requirements.

Exclusion

Exclusion Criteria:

  • Subject is enrolled in a concurrent study that has not been approved for concurrentenrollment by the global study manager.

  • Subject with exclusion criteria required by local law.

Study Design

Total Participants: 500
Study Start date:
July 23, 2024
Estimated Completion Date:
July 01, 2027

Study Description

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.

Connect with a study center

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • McGill University Health Centre (MUHC)

    Montreal, Quebec H3G 1A4
    Canada

    Active - Recruiting

  • Centre Hospitalier Universitaire de Grenoble - Site Nord

    Grenoble, 38700
    France

    Active - Recruiting

  • Hôpital Privé Jacques Cartier

    Massy, 91300
    France

    Active - Recruiting

  • Asklepios Klinik St Georg

    Hamburg, 20099
    Germany

    Site Not Available

  • St. Vincenz-Krankenhaus Paderborn

    Paderborn, 33098
    Germany

    Active - Recruiting

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar Di Valpolicella, Verona 37024
    Italy

    Active - Recruiting

  • St Antonius Ziekenhuis

    Nieuwegein, 3435 CM
    Netherlands

    Active - Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medyczneg

    Lódź, 92-213
    Poland

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Basildon and Thurrock University Hospitals

    Basildon, SS16 5NL
    United Kingdom

    Site Not Available

  • University Hospitals Coventry & Warwickshire

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

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