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

Recruiting

Conditions

Intervention / Treatment

Device: Implantation of the Solia CSP S pacing lead for LBBAP

Study Type

Observational

Enrollment (Estimated)

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

Name: Johannes Pfaffenberger
Phone Number: 1318 +493068905
Email: csp-stream@biotronik.com

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
    - Hopital Gabriel Montpied
  - Marseille, France
    - Not yet recruiting
    - hopital 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 Leveque
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

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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

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

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)

May 25, 2026

Primary Completion (Estimated)

February 1, 2033

Study Completion (Estimated)

February 1, 2033

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

BA118

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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.