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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 |