BIO|STREAM.CSP Study
Recruiting now
Conditions studied: Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices, Bradycardia, Tachycardia, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT07393009
- Run by
- Biotronik SE & Co. KG
- People needed
- 1000
- Starts
- 2026-05-25
- Expected to finish
- 2033-02-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- A.O.U. Maggiore della Carita di Novara — Novara, Italy (enrolling)
- Central Hospital of Northern Pest - Military Hospital — Budapest, Hungary (enrolling)
- University of Pécs — Pécs, Hungary (enrolling)
- 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
- Semmelweis University — Budapest, 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
- Ospedale di Piove di Sacco — Piove di Sacco, Italy
- Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore — Roma, Italy
Full record on ClinicalTrials.gov
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