Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
ConditionCardiac Arrhythmia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiotronik SE & Co. KG
About this trial
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.
Eligibility criteria
Qualifiers
Indication for diagnostic or therapeutic EP intervention
BIOTRONIK catheter (AlCath, ViaCath, MultiCath, Khelix)
BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)
BIOTRONIK transseptal sheath (Senovo Bi-Flex)
Disqualifiers
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
Trial design
Treatments tested in this trial
- BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov