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Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Sponsor: Biotronik SE & Co. KG
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
280
Start Date
2023-01-16
Completion Date
2030-07
Last Updated
2025-09-17
Healthy Volunteers
No
Conditions
Interventions
BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)
Ablations and diagnostic catheters are indicated for temporary transvenous application in patients with cardiac arrhythmias during electrophysiology study (EPS) or catheter ablation interventions. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.
Locations (1)
Städtisches Krankenhaus Friedrichshafen
Friedrichshafen, Germany