Collecting data on the safety and performance of BIOTRONIK EP products for cardiac arrhythmia.
Official title: Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
Run by Biotronik SE & Co. KG · NCT05560958 · Data updated 2026-11-12
This study is testing how safe and effective BIOTRONIK's heart devices are for people getting treatment for heart rhythm problems.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | Biotronik SE & Co. KG Industry-sponsored |
| Locations | 1 site (Bernau bei Berlin, Brandenburg) |
| Status | Recruiting |
| Started | January 16, 2023 |
| Main results expected | July 2030 |
| Study ends | July 2030 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT05560958 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who require a diagnostic or therapeutic EP intervention involving BIOTRONIK EP products.
✕Probably not a fit
Patients who are pregnant, breastfeeding, or have participated in this study previously will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to gather data from routine care to evaluate the safety, performance, and clinical benefits of BIOTRONIK's electrophysiology (EP) products used in procedures for cardiac arrhythmias. It is a prospective, multi-center, international, open-label study that will monitor residual and emerging risks associated with these products. Patients undergoing diagnostic or therapeutic catheter interventions that involve BIOTRONIK EP products will be included, and their outcomes will be assessed to support regulatory compliance and product approval in the CE region.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the safety and effectiveness of BIOTRONIK EP products, leading to improved patient care in cardiac arrhythmia management.
How similar studies have gone: While this study is observational and focuses on post-market data collection, similar studies have successfully demonstrated the safety and efficacy of medical devices in clinical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
-
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany Recruiting
Study contacts
- Study coordinator: Annette Thiem, Dr.
- Email: annette.thiem@biotronik.com
- Phone: +49 (0) 151 6890
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.