BIO|STREAM.CSP Study (BIO|STREAM-CSP)

June 24, 2026 updated by: Biotronik SE & Co. KG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Adelaide, Australia
        • Not yet recruiting
        • Integral Healthcare
  • Austria
      • Linz, Austria
        • Not yet recruiting
        • Kepler Universitätsklinikum GmbH
  • Czechia
      • Olomouc, Czechia
        • Not yet recruiting
        • Fakultni Nemocnice Olomouc
      • Prague, Czechia
        • Not yet recruiting
        • FN Kralovske Vinohrady
  • France
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Hôpital Gabriel Montpied
      • Marseille, France
        • Not yet recruiting
        • Hôpital de la Timone
      • Metz, France
        • Not yet recruiting
        • Centre Hospitalier Metz-Thionville
      • Nantes, France
        • Not yet recruiting
        • Hopital prive du Confluent
      • Pessac, France
        • Not yet recruiting
        • Hopital Haut Lévêque
  • Germany
      • Bad Krozingen, Germany
        • Not yet recruiting
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
      • Bad Nauheim, Germany
        • Not yet recruiting
        • Kerckhoff-Klinik GmbH
      • Bad Oeynhausen, Germany
        • Not yet recruiting
        • Herz- und Diabeteszentrum NRW
      • Cologne, Germany
        • Not yet recruiting
        • Krankenhaus Porz am Rhein gGmbH
      • Osnabrück, Germany
        • Not yet recruiting
        • Niels-Stensen-Kliniken, Marienhospital Osnabrück
  • Hungary
      • Budapest, Hungary
        • Not yet recruiting
        • Semmelweis University
      • Budapest, Hungary
        • Recruiting
        • Central Hospital of Northern Pest - Military Hospital
      • Pécs, Hungary
        • Recruiting
        • University of Pecs
      • Szeged, Hungary
        • Not yet recruiting
        • University Of Szeged
  • Israel
      • Ashdod, Israel
        • Not yet recruiting
        • Assuta Medical Center
      • Beersheba, Israel
        • Not yet recruiting
        • Soroka Medical Center
      • Hadera, Israel
        • Not yet recruiting
        • Hillel Yaffe Medical Center
      • Jerusalem, Israel
        • Not yet recruiting
        • Shaare Zedek Mc
      • Tel Aviv, Israel
        • Not yet recruiting
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Brindisi, Italy
        • Not yet recruiting
        • Ospedale Di Summa - Perrino
      • Milan, Italy
        • Not yet recruiting
        • Niguarda Hospital
      • Novara, Italy
        • Recruiting
        • A.O.U. Maggiore della Carita di Novara
      • Piove di Sacco, Italy
        • Not yet recruiting
        • Ospedale di Piove di Sacco
      • Roma, Italy
        • Not yet recruiting
        • Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore
      • Taranto, Italy
        • Not yet recruiting
        • SS Annunziata Taranto
  • Latvia
      • Riga, Latvia
        • Not yet recruiting
        • Pauls Stradins Clinical University Hospital
  • New Zealand
      • Grafton, New Zealand
        • Not yet recruiting
        • Auckland City Hospital
  • Portugal
      • Coimbra, Portugal
        • Not yet recruiting
        • Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra
      • Lisbon, Portugal
        • Not yet recruiting
        • Unidade Local de Saúde de Santa Maria, E. P. E.
      • Lisbon, Portugal
        • Not yet recruiting
        • Unidade local de Saúde de Sao José, EPE - Hospital Santa Marta
  • Spain
      • Barcelona, Spain
        • Not yet recruiting
        • Hospital Universitari Germans Trias i Pujol
      • Madrid, Spain
        • Not yet recruiting
        • Hospital La Luz
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitario La Fe
      • Valencia, Spain
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
  • Switzerland
      • Bern, Switzerland
        • Not yet recruiting
        • Inselspital, Universitätsspital Bern
      • Zurich, Switzerland
        • Not yet recruiting
        • Universitätsspital Zürich (USZ)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
throughout study duration, average of 4 years; annual evaluations
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.
Day 1
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.
Day 1
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.
throughout study duration, average of 4 years; annual evaluations
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.
throughout study duration, average of 4 years; annual evaluations
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.
throughout study duration, average of 4 years; annual evaluations
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.
throughout study duration, average of 4 years; annual evaluations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BA118

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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