NCT05560958

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 280 (estimated)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cardiac Arrhythmia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-16
• Primary completion: 2030-07-01
• Completion: 2030-07-01
• First posted: 2022-09-30
• Last updated: 2025-09-17

Locations

1 site across 1 country: Germany