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

Recruiting now

Conditions studied: Cardiac Arrhythmia

In brief

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 facts

Study ID

NCT05560958

Run by

Biotronik SE & Co. KG

People needed

280

Starts

2023-01-16

Expected to finish

2030-07-01

Last updated by the study team

2025-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 catheter (AlCath, ViaCath, MultiCath, Khelix)
• BIOTRONIK external device (Qubic Stim, Qubic RF, Qiona)
• BIOTRONIK transseptal sheath (Senovo Bi-Flex)
• 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

You may not qualify if…

• 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

Where it is running

• Städtisches Krankenhaus Friedrichshafen — Friedrichshafen, Germany (enrolling)

Full record on ClinicalTrials.gov

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