Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
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.
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 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:
ines.danzke@biotronik.com+49 (0) 151 6890 ext. 1352
annette.thiem@biotronik.com+49 (0) 151 6890 ext. 1303