Affera Global Registry
Recruiting · NCT06026345 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medtronic Cardiac Ablation Solutions
View the official record on ClinicalTrials.gov →Interventions studied
Affera Platform
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
12 locations listed.
- Charité Universitätsmedizin Berlin, DHZC - Campus Charité Mitte - Berlin, Germany
- Inselspital - Universitätsspital Bern - Bern, Switzerland
- Hôpital Haut-Lévêque - CHU de Bordeaux - Bordeaux, France
- Universitair Ziekenhuis Brussel - Brussels, Belgium
- Royal Papworth Hospital NHS Foundation Trust - Cambridge, United Kingdom
- Beacon Hospital - Dublin, Ireland
- MVZ CCB Frankfurt und Main Taunus GbR - Frankfurt, Germany
- Universitäres Herzzentrum - Hamburg, Germany
- Imperial College Healthcare NHS Trust - Hammersmith Hospital - London, United Kingdom
- IKEM - Institut Klinické a Experimentální Medicíny - Prague, Czechia
- Nemocnice Na Homolce - Prague, Czechia
- Clinique Pasteur - Toulouse, France