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

NCT05560958 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 280

Last updated 2025-09-17

No results posted yet for this 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.

Conditions

  • Cardiac Arrhythmia

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2030-07-31
Completion
2030-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560958 on ClinicalTrials.gov