BIO|STREAM.CSP Study
Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)
1 other identifier
observational
1,000
12 countries
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 6, 2026
CompletedStudy Start
First participant enrolled
May 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2033
June 29, 2026
June 1, 2026
6.7 years
January 9, 2026
June 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
SADE-d free rate related to any investigatonal device
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
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
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
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
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
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
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
Interventions
Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP)
Eligibility Criteria
The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Integral Healthcare
Adelaide, Australia
Kepler Universitätsklinikum GmbH
Linz, Austria
Fakultní nemocnice Olomouc
Olomouc, Czechia
FN Kralovske Vinohrady
Prague, Czechia
Hôpital Gabriel Montpied
Clermont-Ferrand, France
Hôpital de la Timone
Marseille, France
Centre Hospitalier Metz-Thionville
Metz, France
Hôpital privé du Confluent
Nantes, France
Hôpital Haut Lévêque
Pessac, France
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Krankenhaus Porz am Rhein gGmbH
Cologne, Germany
Niels-Stensen-Kliniken, Marienhospital Osnabrück
Osnabrück, Germany
Central Hospital of Northern Pest - Military Hospital
Budapest, Hungary
Semmelweis University
Budapest, Hungary
University of Pécs
Pécs, Hungary
University of Szeged
Szeged, Hungary
Assuta Medical Center
Ashdod, Israel
Soroka Medical Center
Beersheba, Israel
Hillel Yaffe Medical Center
Hadera, Israel
Shaare Zedek MC
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Ospedale Di Summa - Perrino
Brindisi, Italy
Niguarda Hospital
Milan, Italy
A.O.U. Maggiore della Carita di Novara
Novara, Italy
Ospedale di Piove di Sacco
Piove di Sacco, Italy
Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore
Roma, Italy
SS Annunziata Taranto
Taranto, Italy
Pauls Stradins Clinical University Hospital
Riga, Latvia
Auckland City Hospital
Grafton, New Zealand
Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra
Coimbra, Portugal
Unidade Local de Saúde de Santa Maria, E. P. E.
Lisbon, Portugal
Unidade local de Saúde de Sao José, EPE - Hospital Santa Marta
Lisbon, Portugal
Hospital Universitari Germans Trias i Pujol
Barcelona, Spain
Hospital La Luz
Madrid, Spain
Hospital Universitario 12 de Octubre
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Inselspital, Universitätsspital Bern
Bern, Switzerland
Universitätsspital Zürich (USZ)
Zurich, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2026
First Posted
February 6, 2026
Study Start
May 25, 2026
Primary Completion (Estimated)
February 1, 2033
Study Completion (Estimated)
February 1, 2033
Last Updated
June 29, 2026
Record last verified: 2026-06