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

Recruiting

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT05560958
• Lead Sponsor: Biotronik SE & Co. KG

Brief 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.

Detailed Description

In this study, data from routine care will be collected and evaluated to support regulatory post-market clinical follow-up demands under MDR as well as maintenance of the regulatory approval of the BIOTRONIK's EP product portfolio in the CE region. This is a prospective, observational, multi-center, international, open-label, non-randomized study that aims to provide evidence for the clinical safety, performance, and clinical benefit of BIOTRONIK's EP products. The patients participating in the study either receive a diagnostic or therapeutic catheter intervention, which are indicated for temporary transvenous application in patients with cardiac arrhythmias. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.

Study Timeline

• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Study Start: 2023-01-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Device deficiencies	During EP procedure	Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons
Rate of Peri-procedural adverse device effects for each investigational device type	Until or at 24-hour follow-up	Peri-procedural adverse device effects for each investigational device type that occur in all patients until or at the 24-hour follow-up
Percentage of Clinical benefit confirmations per number of use cases	At the time of procedure	Clinical benefit at the time of procedure for each investigational device type
Rate of Post-procedural adverse device effects	After the 24-hour follow-up until or at the 3- to 6-month follow-up	Post-procedural adverse device effects that occur in the AlCath group after the 24-hour follow-up until or at the 3- to 6-month follow-up

Trial Locations

Locations (1)

Städtisches Krankenhaus Friedrichshafen; 🇩🇪 Friedrichshafen, Germany