RecruitingNCT05560958

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

Sponsor

Biotronik SE & Co. KG

Enrollment

280 participants

Start Date

Jan 16, 2023

Study Type

OBSERVATIONAL

Conditions

Cardiac Arrhythmia

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

Min Age: 18 Years

Inclusion Criteria9

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

Exclusion Criteria4

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

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Interventions

DEVICEBIOTRONIK 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.