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

2025-10-07

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

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 (12)

Facility	City	Region	Status
Universitair Ziekenhuis Brussel	Brussels	Belgium	Recruiting
IKEM - Institut Klinické a Experimentální Medicíny	Prague	Czechia	Recruiting
Nemocnice Na Homolce	Prague	Czechia	Recruiting
Hôpital Haut-Lévêque - CHU de Bordeaux	Bordeaux	France	Recruiting
Clinique Pasteur	Toulouse	France	Recruiting
Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte	Berlin	Germany	Recruiting
MVZ CCB Frankfurt und Main Taunus GbR	Frankfurt	Germany	Recruiting
Universitäres Herzzentrum	Hamburg	Germany	Recruiting
Beacon Hospital	Dublin	Ireland	Recruiting
Inselspital - Universitätsspital Bern	Bern	Switzerland	Recruiting
Royal Papworth Hospital NHS Foundation Trust	Cambridge	United Kingdom	Recruiting
Imperial College Healthcare NHS Trust - Hammersmith Hospital	London	United Kingdom	Recruiting

Other trials for the same condition

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF Recruiting

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

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