Collecting data on the safety and performance of BIOTRONIK EP products for cardiac arrhythmia.
Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products
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 |
|---|---|
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotronik SE & Co. KG Industry-sponsored |
| Locations | 1 site (Friedrichshafen) |
| Trial ID | NCT05560958 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require a diagnostic or therapeutic EP intervention involving BIOTRONIK EP products.
Not a fit: Patients who are pregnant, breastfeeding, or have participated in this study previously will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Friedrichshafen
- Städtisches Krankenhaus Friedrichshafen — Friedrichshafen, Germany (Recruiting)
Study contacts
- Study coordinator: Ines Danzke
- Email: ines.danzke@biotronik.com
- Phone: +49 (0) 151 6890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.