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.
• Indication for diagnostic or therapeutic EP intervention
• EP intervention is planned to involve the use of BIOTRONIK EP products from at least 2 of the 3 following categories:
‣ BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)
⁃ BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)
⁃ BIOTRONIK transseptal sheath (Senovo Bi-Flex)
• BIOTRONIK EP product is planned to be used within its intended purpose
• Ability to understand the nature of the study
• Willingness to provide written informed consent
• Ability and willingness to perform all follow-up visits at the study site