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Clinical Trials in Ireland / NCT06026345
Active, not recruiting Observational

Affera Global Registry

NCT06026345 · tracked via the Priya Life Science Ireland tracker
Sponsor
Medtronic Cardiac Ablation Solutions
Phase
Observational
Started
2023-12-22
Last updated
2026-10-09

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Affera Platform

Affera Platform: A cardiac ablation will be performed using the Affera Platform

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Primary Objective #1 (Efficacy) — 12 Month Post Proceedure
    Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.

Trial sites (20)

FacilityCityRegionStatus
Ordensklinikum Linz GmbH / Elisabethinen Linz Austria
Universitair Ziekenhuis Brussel Brussels Belgium
IKEM - Institut Klinické a Experimentální Medicíny Prague Czechia
Nemocnice Na Homolce Prague Czechia
Hôpital Haut-Lévêque - CHU de Bordeaux Bordeaux France
Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord Saint-Priest-en-Jarez France
Clinique Pasteur Toulouse France
Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte Berlin Germany
MVZ CCB Frankfurt und Main Taunus GbR Frankfurt Germany
Universitäres Herzzentrum Hamburg Germany
Onassis Cardiac Surgery Center Kallithea Greece
Beacon Hospital Dublin Ireland
Azienda Ospedaliero Universitaria delle Marche Ancona Italy
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH) Bratislava Slovakia
Hospital Clínico San Carlos Madrid Spain
Hospital Universitario y Politécnico La Fe Valencia Spain
Karolinska Universitetssjukhuset Stockholm Sweden
Inselspital - Universitätsspital Bern Bern Switzerland
Royal Papworth Hospital NHS Foundation Trust Cambridge United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital London United Kingdom

Other trials for the same condition

A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation Active, not recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Active, not recruiting
Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06026345 on ClinicalTrials.gov ↗ ← All trials in Ireland