Affera Global Registry

October 2, 2025 updated by: Medtronic Cardiac Ablation Solutions

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

540

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel
        • Contact:
  • Czechia
      • Prague, Czechia, 15030
        • Recruiting
        • Nemocnice na Homolce
        • Contact:
      • Prague, Czechia, 14021
        • Recruiting
        • IKEM - Institut klinicke a experimentalni mediciny
        • Contact:
          • Jozef Kautzner
          • Phone Number: +420236055006
          • Email: joka@ikem.cz
  • France
      • Bordeaux, France, 33604
        • Recruiting
        • Hôpital Haut-Lévêque - CHU de Bordeaux
        • Contact:
      • Toulouse, France, 31076
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte
        • Contact:
      • Frankfurt, Germany, 60431
        • Recruiting
        • MVZ CCB Frankfurt und Main Taunus GbR
        • Contact:
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitäres Herzzentrum
        • Contact:
  • Ireland
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital - Universitätsspital Bern
        • Contact:
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0AY
        • Recruiting
        • Royal Papworth Hospital NHS Foundation Trust
        • Contact:
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust - Hammersmith Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Arm
Patients enrolled and treated with the Affera Platform
Device: Affera Platform
A cardiac ablation will be performed using the Affera Platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Month Post Proceedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective #2 (Safety)
Time Frame: 90 Days Post Proceedure
Estimate serious device and serious procedure-related adverse events for the Affera Platform.
90 Days Post Proceedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Ablation Solutions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2023

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Estimated)

October 7, 2025

Last Update Submitted That Met QC Criteria

October 2, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Affera Global Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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