RecruitingOBSERVATIONAL

Affera Global Registry

This study, called the Affera Global Registry, is designed to observe how the Affera Platform performs in real-life situations for patients with an irregular heart rhythm known as Atrial Fibrillation. It’s not a trial testing a new unapproved drug, but rather a way to collect information on a device that is already commercially available. Researchers will look at how safe the Affera Platform is and how well it works for a wide range of patients around the world. The goal is to understand its clinical use and track its performance in people receiving this treatment as part of their routine care, helping medical professionals learn more about its effects over time.

At a glance

Status

Recruiting

Sponsor

Medtronic Cardiac Ablation Solutions

Enrolment target

540

Start

22 Dec 2023

Estimated completion

01 Jul 2028

Atrial Fibrillation

What is this study about?

This study is called the Affera Global Registry, and it's about a medical device known as the Affera Platform, which is used to treat a heart condition called Atrial Fibrillation. Atrial Fibrillation causes your heart to beat irregularly and can make you feel tired, dizzy, or short of breath. The Affera Platform is a treatment option that doctors might use to help manage this condition.

Unlike studies that test brand new treatments, this registry observes how the Affera Platform works in people who are already receiving it as part of their regular medical care. Think of it like gathering feedback on a well-known product after it's been released. Doctors and researchers want to understand how safe and effective the device is when used by many different patients in various hospitals worldwide.

The main purpose is to collect detailed information on how the device performs in the real world. This helps doctors learn more about who benefits most from the Affera Platform, what side effects might occur, and how it impacts people's health over time. This information is very important for improving patient care and making sure treatments are as safe and effective as possible.

Key takeaways

This study observes an existing treatment for Atrial Fibrillation.
It aims to gather real-world data on device safety and performance.
No new medical procedures or drugs are given for the study.
Your participation helps improve understanding of the Affera Platform.
You must be having the Affera Platform procedure to be eligible.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old, or meet your local age requirements if they are different. You must also be planning to have a procedure using the Affera Platform, which is already available for medical use.

It's important that you are willing and able to follow all the study instructions and give your informed consent. This means understanding what the study involves and agreeing voluntarily to take part, either in writing or as required by your hospital and local rules.

You cannot join this study if you are already taking part in another study that hasn't been specifically approved to run alongside this one. Also, any other local legal rules that prevent you from joining will apply.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you planning to have a procedure using the Affera Platform?
Are you willing to agree to participate and follow study guidelines?
Are you not currently in another study that conflicts with this one?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would mostly revolve around your planned procedure with the Affera Platform. Researchers would then collect information from your medical records regarding how the procedure went, how you recovered, and how the device is working for you over time. This is an 'observational' study, meaning you won't be given any new or additional treatments specifically for the study itself; instead, information will be gathered from your routine medical care.

There won't be any extra visits or assessments beyond what your doctor would normally recommend for your condition and treatment. The study will mainly involve doctors collecting data from your medical check-ups and follow-up appointments that you would have anyway. The total duration of your participation will depend on how long the registry continues to collect information, but it won't add extra appointments to your schedule.

Potential risks and benefits

Taking part in this study doesn't involve new medical procedures or treatments, so there aren't direct medical benefits beyond the treatment you would already be receiving with the Affera Platform. However, your participation helps doctors and researchers understand more about how the device works for many patients, which can improve care for others in the future. As this is an observational study, the risks are generally minimal, as no additional medical interventions are performed just for the study. The risks associated with the Affera Platform procedure itself are those your doctor would discuss with you as part of your standard care. Remember, you have the right to withdraw from the study at any time without affecting your medical treatment.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Universitair Ziekenhuis Brussel
Verified postcode
Brussels, Belgium· Recruiting
IKEM - Institut Klinické a Experimentální Medicíny
Verified postcode
Prague, Czechia· Recruiting
Nemocnice Na Homolce
Verified postcode
Prague, Czechia· Recruiting
Hôpital Haut-Lévêque - CHU de Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Clinique Pasteur
Verified postcode
Toulouse, France· Recruiting
Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte
Verified postcode
Berlin, Germany· Recruiting
MVZ CCB Frankfurt und Main Taunus GbR
Verified postcode
Frankfurt, Germany· Recruiting
Universitäres Herzzentrum
Verified postcode
Hamburg, Germany· Recruiting
Beacon Hospital
Verified postcode
Dublin, Ireland· Recruiting
Inselspital - Universitätsspital Bern
Verified postcode
Bern, Switzerland· Recruiting
Royal Papworth Hospital NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust - Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Atrial Fibrillation?

Atrial Fibrillation is a common heart condition that causes your heart to beat irregularly, often faster than normal. This can lead to symptoms like tiredness, dizziness, and shortness of breath.

Is the Affera Platform a new, experimental treatment?

No, the Affera Platform is a commercially available medical device that doctors already use. This study is observing how it works in real patients, not testing if it's safe or effective for the first time.

Will I have extra doctor's appointments if I join?

No, this study only collects information from your existing medical records and routine follow-up appointments. You won't have any extra visits just for the study.

What information will the study collect about me?

The study will collect information related to your medical condition, how the Affera Platform procedure went, and how you are feeling afterwards. Your medical team will explain what data will be used.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time without needing to give a reason. This will not affect your medical care.

How to find out more

Libby Bergmann

libby.bergmann@medtronic.com libby.bergmann@medtronic.com Official trial record

Always speak to your GP or specialist before deciding to take part in a study.