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

Cardiac Arrhythmia Clinical Trial

— BIO|COLLECT-EP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560958
• Other study ID #: EP035
• Status: Recruiting
• Start date: January 16, 2023
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Biotronik SE & Co. KG
• Contact: Ines Danzke
• Phone: +49 (0) 151 6890
• Email: ines.danzke[@]biotronik.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Device:
• BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)
Ablations and diagnostic catheters are indicated for temporary transvenous application in patients with cardiac arrhythmias during electrophysiology study (EPS) or catheter ablation interventions. They will be used in combination with external devices like RF generators, external pacemakers cardiac stimulators and / or irrigation pumps.

Locations

Country	Name	City	State
Germany	Städtisches Krankenhaus Friedrichshafen	Friedrichshafen

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Procedural parameters	Fluoroscopy time, Procedure duration, duration of RF energy delivery, date and time of procedure	Intervention
Other	Patient details	demographics, medical history, and concomitant cardiovascular medication	Baseline
Other	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
Primary	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
Primary	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
Primary	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
Primary	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