Affera Global Registry

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: Affera Platform

• Registration Number: NCT06026345
• Lead Sponsor: Medtronic Cardiac Ablation Solutions

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-07
• Study Start: 2023-12-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2028-04-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

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
• Subject with exclusion criteria required by local law

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Affera Platform	Patients enrolled and treated with the Affera Platform

Primary Outcome Measures

Name	Time	Method
Primary Objective #1 (Efficacy)	12 Month Post Proceedure	Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.

Secondary Outcome Measures

Name	Time	Method
Primary Objective #2 (Safety)	90 Days Post Proceedure	Estimate serious device and serious procedure-related adverse events for the Affera Platform.

Trial Locations

Locations (10)

Universitair Ziekenhuis Brussel; 🇧🇪 Brussel, Belgium

IKEM - Institut Klinické a Experimentální Medicíny; 🇨🇿 Praha 4, Czech Republic

Nemocnice Na Homolce; 🇨🇿 Praha 5, Czech Republic

Hôpital Haut-Lévêque - CHU de Bordeaux; 🇫🇷 Bordeaux, France

Clinique Pasteur; 🇫🇷 Toulouse Cedex 3, France

Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte; 🇩🇪 Berlin, Germany

MVZ CCB Frankfurt und Main Taunus GbR; 🇩🇪 Frankfurt, Germany

Universitäres Herzzentrum; 🇩🇪 Hamburg, Germany

Beacon Hospital; 🇮🇪 Dublin, Ireland

Inselspital - Universitätsspital Bern; 🇨🇭 Bern, Switzerland