Affera Global Registry

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

Phase

N/A

Condition

Chest Pain

Cardiac Disease

Atrial Fibrillation

Treatment

Affera Platform

Clinical Study ID

NCT06026345
Affera Global Registry
  • Ages > 18
  • All Genders

Study Summary

The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR). The purpose of this study is to describe clinical performance and safety data in a broad patient population treated with the Affera Platform.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is ≥ 18 years of age or minimum age as required by local regulations

  • Planned procedure using the commercially available Affera Platform

  • Willing and able to comply with study requirements and give IC (defined as legallyeffective, documented confirmation of a subject's voluntary agreement to participatein this clinical study) or authorization per institution and geographicalrequirements

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: 540
Treatment Group(s): 1
Primary Treatment: Affera Platform
Phase:
Study Start date:
December 22, 2023
Estimated Completion Date:
July 01, 2028

Connect with a study center

  • Universitair Ziekenhuis Brussel

    Brussel, 1090
    Belgium

    Active - Recruiting

  • IKEM - Institut Klinické a Experimentální Medicíny

    Praha 4, 14021
    Czech Republic

    Active - Recruiting

  • Nemocnice Na Homolce

    Praha 5, 15030
    Czech Republic

    Active - Recruiting

  • Hôpital Haut-Lévêque - CHU de Bordeaux

    Bordeaux, 33604
    France

    Active - Recruiting

  • Clinique Pasteu

    Toulouse Cedex 3, 31076
    France

    Active - Recruiting

  • Clinique Pasteur

    Toulouse Cedex 3, 31076
    France

    Active - Recruiting

  • Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte

    Berlin, 10117
    Germany

    Active - Recruiting

  • MVZ CCB Frankfurt und Main Taunus GbR

    Frankfurt, 60431
    Germany

    Active - Recruiting

  • Universitäres Herzzentrum

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Beacon Hospital

    Dublin, D18 AK68
    Ireland

    Active - Recruiting

  • Inselspital - Universitätsspital Bern

    Bern, 3010
    Switzerland

    Active - Recruiting

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