Cardiac Arrhythmia Clinical Trial
Official title:
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
This data collection is designed to provide evidence for the safety, performance, and clinical benefit of BIOTRONIK's EP products. Additionally, residual risks will be monitored and newly emerging risks identified.
In this study, data from routine care will be collected and evaluated to support regulatory post-market clinical follow-up demands under MDR as well as maintenance of the regulatory approval of the BIOTRONIK's EP product portfolio in the CE region. This is a prospective, observational, multi-center, international, open-label, non-randomized study that aims to provide evidence for the clinical safety, performance, and clinical benefit of BIOTRONIK's EP products. The patients participating in the study either receive a diagnostic or therapeutic catheter intervention, which are indicated for temporary transvenous application in patients with cardiac arrhythmias. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps. ;
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