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

Launched by BIOTRONIK SE & CO. KG · Sep 27, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of BIOTRONIK's electrophysiology (EP) products, which are used to treat heart rhythm problems known as cardiac arrhythmias. The goal is to gather information on how well these devices work in real-life situations and to keep an eye out for any new risks that may arise during their use.

To participate in this study, you need to be between the ages of 65 and 74 and have a planned procedure that involves using at least two different types of BIOTRONIK devices, such as catheters or external devices. You should be able to understand the study's purpose and agree to follow up with the research team after your procedure. If you decide to join, you'll help researchers learn more about these products, which may ultimately improve care for patients with heart rhythm issues.

Gender

ALL

Eligibility 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