Affera Global Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Affera Platform.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Czechia, France, Germany, Ireland +2
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
Overview
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.
Interventions
- Device Affera Platform
A cardiac ablation will be performed using the Affera Platform
Primary outcome measures
- Primary Objective #1 (Efficacy) [Time frame: 12 Month Post Proceedure]
Secondary outcome measures (1)
- Primary Objective #2 (Safety) [Time frame: 90 Days Post Proceedure]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 3 centers
- Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte — Berlin
- MVZ CCB Frankfurt und Main Taunus GbR — Frankfurt
- Universitäres Herzzentrum — Hamburg
Czechia · 2 centers
- IKEM - Institut Klinické a Experimentální Medicíny — Prague
- Nemocnice Na Homolce — Prague
France · 2 centers
- Hôpital Haut-Lévêque - CHU de Bordeaux — Bordeaux
- Clinique Pasteur — Toulouse
United Kingdom · 2 centers
- Royal Papworth Hospital NHS Foundation Trust — Cambridge
- Imperial College Healthcare NHS Trust - Hammersmith Hospital — London
Belgium · 1 center
- Universitair Ziekenhuis Brussel — Brussels
Ireland · 1 center
- Beacon Hospital — Dublin
Switzerland · 1 center
- Inselspital - Universitätsspital Bern — Bern
Identifiers
NCT: NCT06026345 · Affera Global Registry