Follow-up of People With Heart Devices Using Conduction System Pacing
Follows adults whose heart pacing devices use a Solia lead in routine care.
Plain-language title generated from the registry record
Registry title: BIO|STREAM.CSP Study
Key facts
- Where
- Bergamo, Brindisi, Milan, Novara, Piove di Sacco, Roma, and Taranto, ItalySee the 8 sites
Where in Italy
- Humanitas GavazzeniBergamo, ItalyNot yet recruiting
- Ospedale Di Summa - PerrinoBrindisi, ItalyNot yet recruiting
- Niguarda HospitalMilan, ItalyNot yet recruiting
- A.O.U. Maggiore della Carità di NovaraNovara, ItalyTaking people
- Ospedale di Piove di SaccoPiove di Sacco, ItalyNot yet recruiting
- Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro CuoreRoma, ItalyNot yet recruiting
- Policlinico CasilinoRoma, ItalyNot yet recruiting
- SS Annunziata TarantoTaranto, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biotronik SE & Co. KG
- Trial code
- NCT07393009
- Record updated
- 23 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment; Age less than 18 years; 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.