Affera Global Registry

NCT ID: NCT06026345

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

540 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-22

Study Completion Date

2028-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Arm

Patients enrolled and treated with the Affera Platform

Affera Platform

Intervention Type DEVICE

A cardiac ablation will be performed using the Affera Platform

Interventions

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Affera Platform

A cardiac ablation will be performed using the Affera Platform

Intervention Type DEVICE

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitair Ziekenhuis Brussel

Brussels, , Belgium

Site Status RECRUITING

IKEM - Institut Klinické a Experimentální Medicíny

Prague, , Czechia

Site Status RECRUITING

Nemocnice Na Homolce

Prague, , Czechia

Site Status RECRUITING

Hôpital Haut-Lévêque - CHU de Bordeaux

Bordeaux, , France

Site Status RECRUITING

Clinique Pasteur

Toulouse, , France

Site Status RECRUITING

Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte

Berlin, , Germany

Site Status RECRUITING

MVZ CCB Frankfurt und Main Taunus GbR

Frankfurt, , Germany

Site Status RECRUITING

Universitäres Herzzentrum

Hamburg, , Germany

Site Status RECRUITING

Beacon Hospital

Dublin, , Ireland

Site Status RECRUITING

Inselspital - Universitätsspital Bern

Bern, , Switzerland

Site Status RECRUITING

Royal Papworth Hospital NHS Foundation Trust

Cambridge, , United Kingdom

Site Status RECRUITING

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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Belgium Czechia France Germany Ireland Switzerland United Kingdom

Central Contacts

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Libby Bergmann

Role: CONTACT

Susan Knols

Role: CONTACT

Facility Contacts

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Gian-Battista Chierchia

Role: primary

+3224763509

Jozef Kautzner

Role: primary

+420236055006

Petr Neuzil

Role: primary

+420257272211

Pierre Jais

Role: primary

+33556795679

Serge Boveda

Role: primary

+33 562211645

Verena Tscholl

Role: primary

+4930450613855

Julian Chun

Role: primary

+4969945028110

Andreas Metzner

Role: primary

+4940741058320

Jonathan Lyne

Role: primary

+35312936600

Tobias Reichlin

Role: primary

+41316322111

Greg Mellor

Role: primary

+447967713345

Prapa Kanagaratnam

Role: primary

+442033131000

Other Identifiers

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Affera Global Registry

Identifier Type: -

Identifier Source: org_study_id

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