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Recruiting

NCT Number: NCT07393009

BIO|STREAM.CSP Study

The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.

Recruiting

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Key information

Conditions

Cardiac Pacing Arrhythmias, Cardiac Bradycardia Cardiac Conduction System Disease Cardiac Pacemaker Cardiac Resynchronization Therapy Devices Cardiovascular Diseases Heart Diseases Heart Failure Implantable Cardioverter Defibrillator Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Integral Healthcare, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P/-D)
  • Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO|MASTER.CSP study
  • Ability to understand the nature of the study
  • Ability and willingness to perform all follow-up visits
  • Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept

Exclusion criteria

  • Planned dation from intended use
  • Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment
  • Life-expectancy less than 12 months
  • Pregnant or breast feeding
  • Age less than 18 years
  • Participation in an interventional clinical investigation, except for submodules within this study.

Treatment and study plan

Implantation of the Solia CSP S pacing lead for LBBAP

Device

Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP)

Primary outcomes

  1. SADE-d free rate related to any investigatonal device

    Time frame: throughout study duration, average of 4 years; annual evaluations

    Rate of serious adverse device effects possible, probable or causal related to any investigational device.

  2. Rate of successful acute implantation in LBBAP using investigational devices in LBBAP

    Time frame: Day 1

    All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently deep within the intraventricular septum are counted as acute success.

  3. Capture type at implantation

    Time frame: Day 1

    The investigator confirms the type of pacing capture for any implantation in which the pacing lead is permanently positioned deep within the interventricular septum. Success rates for LBBAP and CSP are determined based on ECG parameters.

  4. Long-term maintenance of LBBAP

    Time frame: throughout study duration, average of 4 years; annual evaluations

    The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording.

  5. Electrical parameters - pacing threshold

    Time frame: throughout study duration, average of 4 years; annual evaluations

    The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms.

  6. Electrical parameters - sensing amplitude

    Time frame: throughout study duration, average of 4 years; annual evaluations

    The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.

  7. Electrical parameters - pacing impedance

    Time frame: throughout study duration, average of 4 years; annual evaluations

    The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.

Study contacts

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

Johannes Pfaffenberger

CONTACT

[email protected]

+493068905 ext. 1318

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Feb 6, 2026
Registry last updated
Jun 29, 2026

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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