The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Universitair Ziekenhuis Brussel
RECRUITING
Brussels
France
Hôpital Haut-Lévêque - CHU de Bordeaux
RECRUITING
Bordeaux
Clinique Pasteur
RECRUITING
Toulouse
Germany
Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte
RECRUITING
Berlin
MVZ CCB Frankfurt und Main Taunus GbR
RECRUITING
Frankfurt
Universitäres Herzzentrum
RECRUITING
Hamburg
Ireland
Beacon Hospital
RECRUITING
Dublin
Switzerland
Inselspital - Universitätsspital Bern
RECRUITING
Bern
United Kingdom
Royal Papworth Hospital NHS Foundation Trust
RECRUITING
Cambridge
Imperial College Healthcare NHS Trust - Hammersmith Hospital
RECRUITING
London
Contact Information
Primary
Libby Bergmann
libby.bergmann@medtronic.com
libby.bergmann@medtronic.com
Backup
Susan Knols
susan.knols@medtronic.com
susan.knols@medtronic.com
Time Frame
Start Date: 2023-12-22
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 540
Treatments
Treatment Arm
Patients enrolled and treated with the Affera Platform
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiac Ablation Solutions