NCT07393009Recruiting
BIO|STREAM.CSP Study
Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Jan 2026
- Start date
- 25 May 2026
- Primary completion date
- 1 Feb 2033
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Heart failure
- NCT number
- NCT07393009
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 25 May 2026 to the primary completion date, 1 Feb 2033
- 46 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment
Age
- Age less than 18 years
Other
- Planned dation from intended use
- Life-expectancy less than 12 months
- Pregnant or breast feeding
- Participation in an interventional clinical investigation, except for submodules within this study.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kepler Universitatsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| Integral Healthcare Coordinator of this site? Confirm its status | Adelaide | Australia | Not yet recruiting |
| Northern Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Not yet recruiting |
| Inselspital Universitätsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Not yet recruiting |
| Universitätsspital Zürich USZ Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
| Fakultni nemocnice Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| FN Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Klinikum Augsburg Coordinator of this site? Confirm its status | Augsburg | Germany | Not yet recruiting |
| Universitäts-Herzzentrum Freiburg - Bad Krozingen Coordinator of this site? Confirm its status | Bad Krozingen | Germany | Not yet recruiting |
| Kerckhoff-Klinik GmbH Coordinator of this site? Confirm its status | Bad Nauheim | Germany | Not yet recruiting |
| Herz- und Diabeteszentrum NRW Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Not yet recruiting |
| Krankenhaus Porz am Rhein gGmbH Coordinator of this site? Confirm its status | Cologne | Germany | Recruiting |
| Niels-Stensen-Kliniken, Marienhospital Osnabrück Coordinator of this site? Confirm its status | Osnabrück | Germany | Not yet recruiting |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Clínico y Provincial de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital La Luz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario la Fe Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Hopital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Centre Hospitalier Metz-Thionville Coordinator of this site? Confirm its status | Metz | France | Not yet recruiting |
| Hôpital Privé du Confluent Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hopital Haut-Leveque Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| Institut Arnaud Tzanck Coordinator of this site? Confirm its status | Saint-Laurent-du-Var | France | Not yet recruiting |
| Central Hospital of Northern Pest - Military Hospital Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Not yet recruiting |
| Assuta Medical Center Coordinator of this site? Confirm its status | Ashdod | Israel | Not yet recruiting |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Not yet recruiting |
| Hillel Yaffe Medical Center Coordinator of this site? Confirm its status | Hadera | Israel | Not yet recruiting |
| Shaare Zedek MC Coordinator of this site? Confirm its status | Jerusalem | Israel | Not yet recruiting |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Not yet recruiting |
| Humanitas Gavazzeni Coordinator of this site? Confirm its status | Bergamo | Italy | Not yet recruiting |
| Ospedale Di Summa - Perrino Coordinator of this site? Confirm its status | Brindisi | Italy | Not yet recruiting |
| Niguarda Hospital Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| A.O.U. Maggiore della Carità di Novara Coordinator of this site? Confirm its status | Novara | Italy | Recruiting |
| Ospedale di Piove di Sacco Coordinator of this site? Confirm its status | Piove di Sacco | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Policlinico Casilino Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| SS Annunziata Taranto Coordinator of this site? Confirm its status | Taranto | Italy | Not yet recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Auckland City Hospital Coordinator of this site? Confirm its status | Grafton | New Zealand | Not yet recruiting |
| Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Not yet recruiting |
| Unidade local de Saúde de Sao José, EPE - Hospital Santa Marta Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.