Post-market Clinical Follow-up Data Collection From Procedures With BIOTRONIK EP Products (BIO|COLLECT-EP)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)

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 Type: Observational
• Enrollment (Estimated): 280

Contacts and Locations

• Study Contact: Name: Ines Danzke; Phone Number: 1352 +49 (0) 151 6890; Email: ines.danzke@biotronik.com
• Study Contact Backup: Name: Annette Thiem, Dr.; Phone Number: 1303 +49 (0) 151 6890; Email: annette.thiem@biotronik.com

Study Locations

• Germany
  • Friedrichshafen, Germany, 88048
    • Recruiting
    • Städtisches Krankenhaus Friedrichshafen
    • Contact: Hansjörg Bauerle, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients indicated for diagnosis and treatment of intracardiac arrhythmias in an EP lab environment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure setting (related to used BIOTRONIK EP products and competitor products)	Type of procedure, type of catheter models, recording system, RF ablation generator, irrigation pump, stimulator, 3D system, patient cable	Intervention
Procedural parameters	Fluoroscopy time, Procedure duration, duration of RF energy delivery, date and time of procedure	Intervention
Patient details	demographics, medical history, and concomitant cardiovascular medication	Baseline
Device performance	e.g., successful insertion and advancing of catheter, successful stimulation and recording of intracardiac signals, RF energy application, removal, replacement/substitution of catheter, device used within its intended purpose	Intervention

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: September 27, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac
• Other Study ID Numbers: EP035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon resonable request by authors or other scientifc reasons, but requires explicit approval by the sponsor.
• IPD Sharing Time Frame: The data will become available with uploading the results to clinical trial.gov. The data will be available as long as the study documents are archived.
• IPD Sharing Access Criteria: On demand; in case of request by an author or in case of scientific reasons, but requires explicit approval by the sponsor.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No