BIO|STREAM.CSP Study
Recruiting · NCT07393009 · Observational (researchers observe without assigning treatment) · Lead sponsor: Biotronik SE & Co. KG
View the official record on ClinicalTrials.gov →Interventions studied
Implantation of the Solia CSP S pacing lead for LBBAP
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
40 locations listed.
- Integral Healthcare - Adelaide, Australia
- Assuta Medical Center - Ashdod, Israel
- Universitäts-Herzzentrum Freiburg Bad Krozingen - Bad Krozingen, Germany
- Kerckhoff-Klinik GmbH - Bad Nauheim, Germany
- Herz- und Diabeteszentrum NRW - Bad Oeynhausen, Germany
- Hospital Universitari Germans Trias i Pujol - Barcelona, Spain
- Soroka Medical Center - Beersheba, Israel
- Inselspital, Universitätsspital Bern - Bern, Switzerland
- Ospedale Di Summa - Perrino - Brindisi, Italy
- Central Hospital of Northern Pest - Military Hospital - Budapest, Hungary
- Semmelweis University - Budapest, Hungary
- Hôpital Gabriel Montpied - Clermont-Ferrand, France
- Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra - Coimbra, Portugal
- Krankenhaus Porz am Rhein gGmbH - Cologne, Germany
- Auckland City Hospital - Grafton, New Zealand
- Hillel Yaffe Medical Center - Hadera, Israel
- Shaare Zedek MC - Jerusalem, Israel
- Kepler Universitätsklinikum GmbH - Linz, Austria
- 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 La Luz - Madrid, Spain
- Hôpital de la Timone - Marseille, France
- Centre Hospitalier Metz-Thionville - Metz, France
- Niguarda Hospital - Milan, Italy
- Hôpital privé du Confluent - Nantes, France
- A.O.U. Maggiore della Carita di Novara - Novara, Italy
- Fakultní nemocnice Olomouc - Olomouc, Czechia
- Niels-Stensen-Kliniken, Marienhospital Osnabrück - Osnabrück, Germany
- Hôpital Haut Lévêque - Pessac, France
- Ospedale di Piove di Sacco - Piove di Sacco, Italy
- FN Kralovske Vinohrady - Prague, Czechia
- University of Pécs - Pécs, Hungary
- Pauls Stradins Clinical University Hospital - Riga, Latvia
- Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore - Roma, Italy
- University of Szeged - Szeged, Hungary
- SS Annunziata Taranto - Taranto, Italy
- Tel Aviv Sourasky Medical Center - Tel Aviv, Israel
- Hospital Universitario 12 de Octubre - Valencia, Spain
- Hospital Universitario La Fe - Valencia, Spain
- Universitätsspital Zürich (USZ) - Zurich, Switzerland