Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
ACTIVE NOT RECRUITINGN/A

Affera Global Registry

Sponsor: Medtronic Cardiac Ablation Solutions

NCT ID: NCT06026345

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Affera Platform (device)
How long the study runs
Study runs about 55 months (dates as stated)
About the drug or intervention
Affera Platform — device: A cardiac ablation will be performed using the Affera Platform
Patient visit burden
Not specified by the sponsor

In plain English

This is a global registry (a type of study that collects information over time) for people with atrial fibrillation, a condition where the heart beats in an irregular rhythm. It is run by Medtronic Cardiac Ablation Solutions, the company that makes the Affera Platform.

Who can take part

  • Adults aged 18 or over, or the minimum age allowed by local rules
  • You are due to have a procedure using the Affera Platform, which is already available for normal use
  • You are willing and able to follow the study requirements and give your written agreement (consent) to take part, in line with your hospital's and local rules

Who may not be able to

  • You are already taking part in another study that has not been approved for joining at the same time by the global study manager
  • You meet any exclusion rules set by local law

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
540
Started
2023-12-22
Last checked
2025-10

Plain English Summary

What is this study?

  • • Testing a new treatment for atrial fibrillation
  • • Clinical study - 540 participants
  • • The Affera Global Registry is a prospective, global, multi-center, observational post-market registry (PMR)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with atrial fibrillation

Where?

  • • Cambridge - Royal Papworth Hospital NHS Foundation Trust
  • • London - Imperial College Healthcare NHS Trust - Hammersmith Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Atrial Fibrillation

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ by local regulations

What the study is looking for

  • ✓Subject is ≥ 18 years of age or minimum age as required by local regulations
  • ✓Planned procedure using the commercially available Affera Platform

Who cannot take part

  • ✗Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study...
  • ✗Subject with exclusion criteria required by local law
See the full criteria
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

Where Is This Study? (2 UK sites)

Royal Papworth Hospital NHS Foundation Trust

Cambridge CB2 0AY, United Kingdom

Hospital R&D contact (matched)

Vikki Hughes

papworth.randdenquiries@nhs.net01223 638000

Imperial College Healthcare NHS Trust - Hammersmith Hospital

London W12 0HS, United Kingdom

Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---
Data sourced from ClinicalTrials.gov · Last verified: 2025-10