RecruitingNCT06026345

Affera Global Registry

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


Sponsor

Medtronic Cardiac Ablation Solutions

Enrollment

540 participants

Start Date

Dec 22, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a registry study (data collection only, no experimental treatment) tracking real-world outcomes for patients who undergo a heart ablation procedure using the commercially available Affera Platform — a system used to treat heart rhythm problems (arrhythmias). The goal is to collect long-term safety and effectiveness data from patients in routine clinical care. **You may be eligible if...** - You are 18 years of age or older (or meet your local minimum age requirement) - You are scheduled to have a procedure using the Affera Platform as part of your normal care - You are willing to follow the study requirements and give your consent **You may NOT be eligible if...** - You are already enrolled in another study that hasn't approved combined enrollment - Your local laws or regulations exclude you from participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEAffera Platform

A cardiac ablation will be performed using the Affera Platform


Locations(12)

Universitair Ziekenhuis Brussel

Brussels, Belgium

IKEM - Institut Klinické a Experimentální Medicíny

Prague, Czechia

Nemocnice Na Homolce

Prague, Czechia

Hôpital Haut-Lévêque - CHU de Bordeaux

Bordeaux, France

Clinique Pasteur

Toulouse, 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

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06026345


Related Trials