Affera Global Registry
The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
1 other identifier
observational
540
7 countries
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2023
CompletedFirst Posted
Study publicly available on registry
September 7, 2023
CompletedStudy Start
First participant enrolled
December 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
October 7, 2025
October 1, 2025
4.3 years
August 30, 2023
October 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Objective #1 (Efficacy)
Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.
12 Month Post Proceedure
Secondary Outcomes (1)
Primary Objective #2 (Safety)
90 Days Post Proceedure
Study Arms (1)
Treatment Arm
Patients enrolled and treated with the Affera Platform
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
IKEM - Institut Klinické a Experimentální Medicíny
Prague, 14021, Czechia
Nemocnice Na Homolce
Prague, 15030, Czechia
Hôpital Haut-Lévêque - CHU de Bordeaux
Bordeaux, 33604, France
Clinique Pasteur
Toulouse, 31076, France
Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte
Berlin, 10117, Germany
MVZ CCB Frankfurt und Main Taunus GbR
Frankfurt, 60431, Germany
Universitäres Herzzentrum
Hamburg, 20246, Germany
Beacon Hospital
Dublin, D18 AK68, Ireland
Inselspital - Universitätsspital Bern
Bern, 3010, Switzerland
Royal Papworth Hospital NHS Foundation Trust
Cambridge, CB2 0AY, United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2023
First Posted
September 7, 2023
Study Start
December 22, 2023
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
October 7, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share