Actively Recruiting
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Led by Biotronik SE & Co. KG · Updated on 2025-09-17
280
Participants Needed
1
Research Sites
389 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Indication for diagnostic or therapeutic electrophysiology (EP) intervention
- EP intervention planned to use BIOTRONIK EP products from at least two of these categories: BIOTRONIK catheters (AlCath, ViaCath, MultiCath, Khelix), BIOTRONIK external devices (Qubic Stim, Qubic RF, Qiona), BIOTRONIK transseptal sheaths (Senovo Bi-Flex)
- BIOTRONIK EP product 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 will not qualify if you...
- Age less than 18 years
- Pregnant or breastfeeding
- Prior participation in this study with performed EP procedure
- Participation in another interventional clinical investigation during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Städtisches Krankenhaus Friedrichshafen
Friedrichshafen, Germany, 88048
Actively Recruiting
Research Team
I
Ines Danzke
CONTACT
A
Annette Thiem, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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