Atrial FibrillationNCT06026345
Affera Global Registry
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 20 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Affera Platform
- Type of treatment
- Medical device
- How many people
- 540 participants
- Where
- 20 sitesin 13 countries
- Study dates
- 22 Dec 2023to 1 Jul 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 13 countries.
20 sites in 13 countries
France3 sites
Hôpital Haut-Lévêque - CHU de Bordeaux
Bordeaux, 33604
Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord
Saint-Priest-en-Jarez, 42270
Clinique Pasteur
Toulouse, 31076
Germany3 sites
Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte
Berlin, 10117
MVZ CCB Frankfurt und Main Taunus GbR
Frankfurt, 60431
Universitäres Herzzentrum
Hamburg, 20246
Czechia2 sites
IKEM - Institut Klinické a Experimentální Medicíny
Prague, 14021
Nemocnice Na Homolce
Prague, 15030
Spain2 sites
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario y Politécnico La Fe
Valencia, 46026
United Kingdom2 sites
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0AY
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, W12 0HS
Slovakia1 site
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
Bratislava, 83348
About this study
Official title: The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Affera Platform
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affera PlatformDevice
A cardiac ablation will be performed using the Affera Platform
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Patients enrolled and treated with the Affera Platform Receives: Device: Affera Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective #1 (Efficacy)
Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.
Measured: 12 Month Post Proceedure
Secondary outcomes (1)
Primary Objective #2 (Safety)
Estimate serious device and serious procedure-related adverse events for the Affera Platform.
Measured: 90 Days Post Proceedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start22 Dec 2023
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026345
- Sponsor's protocol ID
- Affera Global Registry
- Status last verified
- Oct 2025
- First submitted
- 30 Aug 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
- ClinicalTrials.gov ID
- NCT06026345
- Acronym / sponsor ID
- Affera Global Registry
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | – | Device: Affera PlatformPatients enrolled and treated with the Affera Platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affera PlatformA cardiac ablation will be performed using the Affera Platform | Device | Treatment Arm |
Primary outcome
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.
1 secondary outcome
Primary Objective #2 (Safety)
Time frame: 90 Days Post Proceedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 20 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Germany, Czechia, Spain, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective #1 (Efficacy) (time frame: 12 Month Post Proceedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.