Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Rate of Device deficiencies — During EP procedure
  Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons
• Rate of Peri-procedural adverse device effects for each investigational device type — Until or at 24-hour follow-up
  Peri-procedural adverse device effects for each investigational device type that occur in all patients until or at the 24-hour follow-up
• Rate of Post-procedural adverse device effects — After the 24-hour follow-up until or at the 3- to 6-month follow-up
  Post-procedural adverse device effects that occur in the AlCath group after the 24-hour follow-up until or at the 3- to 6-month follow-up
• Percentage of Clinical benefit confirmations per number of use cases — At the time of procedure
  Clinical benefit at the time of procedure for each investigational device type

Trial sites (1)

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