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.
Study Type
OBSERVATIONAL
Enrollment
280
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.
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany
RECRUITINGRate of Device deficiencies
Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons
Time frame: During EP procedure
Rate of Peri-procedural adverse device effects for each investigational device type
Peri-procedural adverse device effects for each investigational device type that occur in all patients until or at the 24-hour follow-up
Time frame: Until or at 24-hour follow-up
Rate of Post-procedural adverse device effects
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
Time frame: 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
Clinical benefit at the time of procedure for each investigational device type
Time frame: At the time of procedure
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