Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age less than 18 years
- Pregnant or breastfeeding
- Prior participation in this study with performed EP procedure
- Participation in an interventional clinical investigation in parallel to the BIO\|COLLECT.EP study
