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Recruiting

NCT Number: NCT06026345

Affera Global Registry

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.

Recruiting

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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

Universitair Ziekenhuis Brussel, Brussels, Belgium

Loading trial locations.

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
  • 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

Treatment and study plan

Affera Platform

Device

A cardiac ablation will be performed using the Affera Platform

Primary outcomes

  1. Primary Objective #1 (Efficacy)

    Time frame: 12 Month Post Proceedure

    Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.

Secondary outcomes

  1. Primary Objective #2 (Safety)

    Time frame: 90 Days Post Proceedure

    Estimate serious device and serious procedure-related adverse events for the Affera Platform.

Study contacts

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

Libby Bergmann

CONTACT

[email protected]

[email protected]

Susan Knols

CONTACT

[email protected]

[email protected]

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Ablation Solutions

Industry

Registry information

Official study title

The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 7, 2023
Registry last updated
Oct 7, 2025

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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