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NCT Number: NCT05560958

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

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.

Recruiting

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Städtisches Krankenhaus Friedrichshafen

Friedrichshafen, 88048, Germany

Location status: Recruiting

Location contact

Hansjörg Bauerle, Dr. med.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIOTRONIK EP catheters (AlCath, MultiCath, ViaCath), external devices (Qubic RF, Qubic Stim, Qiona) and transseptal sheaths (Senovo bi-flex)

Device

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.

Primary outcomes

  1. Rate of Device deficiencies

    Time frame: During EP procedure

    Device deficiencies for each investigational device type that occur during the EP procedures in patients, users or other persons

  2. Rate of Peri-procedural adverse device effects for each investigational device type

    Time frame: 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

  3. Rate of Post-procedural adverse device effects

    Time frame: 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

  4. Percentage of Clinical benefit confirmations per number of use cases

    Time frame: At the time of procedure

    Clinical benefit at the time of procedure for each investigational device type

Other outcomes

  1. Procedure setting (related to used BIOTRONIK EP products and competitor products)

    Time frame: Intervention

    Type of procedure, type of catheter models, recording system, RF ablation generator, irrigation pump, stimulator, 3D system, patient cable

  2. Procedural parameters

    Time frame: Intervention

    Fluoroscopy time, Procedure duration, duration of RF energy delivery, date and time of procedure

  3. Patient details

    Time frame: Baseline

    demographics, medical history, and concomitant cardiovascular medication

  4. Device performance

    Time frame: Intervention

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Annette Thiem, Dr.

CONTACT

[email protected]

+49 (0) 151 6890 ext. 1303

Ines Danzke

CONTACT

[email protected]

+49 (0) 151 6890 ext. 1352

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Acronym: BIO|COLLECT-EP

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Sep 30, 2022
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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