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New heart device registry aims to track Real-World results for AFib patients

NCT ID NCT06026345

Knowledge-focused Sponsor: Medtronic Cardiac Ablation Solutions Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This registry will follow 540 people with atrial fibrillation who are treated with the Affera ablation device. Researchers want to see how well the device stops irregular heart rhythms and how safe it is in everyday medical practice. The study is observational, meaning patients get their normal care, and no new treatments are being tested.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Affera Platform (cardiac ablation device)
What this could lead to
If successful, this registry will provide real-world evidence on how well the Affera device controls atrial fibrillation and its safety profile.
What could go wrong
This is an observational registry, not a controlled trial, so results may be influenced by patient selection and lack a comparison group. It cannot prove the device works better than alternatives.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a recommendation for an ablation with the Affera Platform may be approached regarding enrollment in this study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beacon Hospital

    RECRUITING

    Dublin, D18 AK68, Ireland

  • Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte

    RECRUITING

    Berlin, 10117, Germany

  • Clinique Pasteur

    RECRUITING

    Toulouse, 31076, France

  • Hôpital Haut-Lévêque - CHU de Bordeaux

    RECRUITING

    Bordeaux, 33604, France

  • IKEM - Institut Klinické a Experimentální Medicíny

    RECRUITING

    Prague, 14021, Czechia

  • Imperial College Healthcare NHS Trust - Hammersmith Hospital

    RECRUITING

    London, W12 0HS, United Kingdom

  • Inselspital - Universitätsspital Bern

    RECRUITING

    Bern, 3010, Switzerland

  • MVZ CCB Frankfurt und Main Taunus GbR

    RECRUITING

    Frankfurt, 60431, Germany

  • Nemocnice Na Homolce

    RECRUITING

    Prague, 15030, Czechia

  • Royal Papworth Hospital NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0AY, United Kingdom

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Brussels, 1090, Belgium

  • Universitäres Herzzentrum

    RECRUITING

    Hamburg, 20246, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.