Global registry for patients treated with the Affera Platform for atrial fibrillation
The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
This study is collecting information from patients with atrial fibrillation who are treated with the Affera Platform to see how well it works and how safe it is in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Cardiac Ablation Solutions Industry-sponsored |
| Locations | 12 sites (Brussels and 11 other locations) |
| Trial ID | NCT06026345 on ClinicalTrials.gov |
What this trial studies
The Affera Global Registry is a prospective, multi-center observational registry aimed at collecting clinical performance and safety data from a diverse patient population treated with the Affera Platform for atrial fibrillation. This registry will gather real-world evidence on the effectiveness and safety of the Affera Platform in various clinical settings. Participants will be monitored for outcomes related to their treatment, contributing valuable data to enhance understanding of this intervention's impact.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who are scheduled to undergo a procedure using the Affera Platform.
Not a fit: Patients who are enrolled in other concurrent studies that do not allow for participation in this registry may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could provide critical insights into the safety and effectiveness of the Affera Platform, potentially leading to improved treatment strategies for atrial fibrillation.
How similar studies have performed: While this registry approach is common in post-market evaluations, the specific use of the Affera Platform in this context is novel and aims to gather new data on its clinical performance.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels and 11 other locations
- 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)
Study contacts
- Study coordinator: Libby Bergmann
- Email: libby.bergmann@medtronic.com
- Phone: libby.bergmann@medtronic.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.