Recruiting NCT07393009
BIO|STREAM.CSP Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implantation of the Solia CSP S pacing lead for LBBAP.
- Who it may be relevant to
- Registry conditions: Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Austria, Czechia, France, Germany +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)
Overview
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.
Interventions
- Device Implantation of the Solia CSP S pacing lead for LBBAP
Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP)
Primary outcome measures
- SADE-d free rate related to any investigatonal device [Time frame: throughout study duration, average of 4 years; annual evaluations]
- Rate of successful acute implantation in LBBAP using investigational devices in LBBAP [Time frame: Day 1]
- Capture type at implantation [Time frame: Day 1]
- Long-term maintenance of LBBAP [Time frame: throughout study duration, average of 4 years; annual evaluations]
- Electrical parameters - pacing threshold [Time frame: throughout study duration, average of 4 years; annual evaluations]
- Electrical parameters - sensing amplitude [Time frame: throughout study duration, average of 4 years; annual evaluations]
- Electrical parameters - pacing impedance [Time frame: throughout study duration, average of 4 years; annual evaluations]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 6 centers
- Ospedale Di Summa - Perrino — Brindisi
- Niguarda Hospital — Milan
- A.O.U. Maggiore della Carita di Novara — Novara
- Ospedale di Piove di Sacco — Piove di Sacco
- Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuo — Roma
- SS Annunziata Taranto — Taranto
France · 5 centers
- Hôpital Gabriel Montpied — Clermont-Ferrand
- Hôpital de la Timone — Marseille
- Centre Hospitalier Metz-Thionville — Metz
- Hôpital privé du Confluent — Nantes
- Hôpital Haut Lévêque — Pessac
Germany · 5 centers
- Universitäts-Herzzentrum Freiburg Bad Krozingen — Bad Krozingen
- Kerckhoff-Klinik GmbH — Bad Nauheim
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen
- Krankenhaus Porz am Rhein gGmbH — Cologne
- Niels-Stensen-Kliniken, Marienhospital Osnabrück — Osnabrück
Israel · 5 centers
- Assuta Medical Center — Ashdod
- Soroka Medical Center — Beersheba
- Hillel Yaffe Medical Center — Hadera
- Shaare Zedek MC — Jerusalem
- Tel Aviv Sourasky Medical Center — Tel Aviv
Hungary · 4 centers
- Central Hospital of Northern Pest - Military Hospital — Budapest
- Semmelweis University — Budapest
- University of Pécs — Pécs
- University of Szeged — Szeged
Spain · 4 centers
- Hospital Universitari Germans Trias i Pujol — Barcelona
- Hospital La Luz — Madrid
- Hospital Universitario 12 de Octubre — Valencia
- Hospital Universitario La Fe — Valencia
Portugal · 3 centers
- Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra — Coimbra
- Unidade Local de Saúde de Santa Maria, E. P. E. — Lisbon
- Unidade local de Saúde de Sao José, EPE - Hospital Santa Marta — Lisbon
Czechia · 2 centers
- Fakultní nemocnice Olomouc — Olomouc
- FN Kralovske Vinohrady — Prague
Switzerland · 2 centers
- Inselspital, Universitätsspital Bern — Bern
- Universitätsspital Zürich (USZ) — Zurich
Australia · 1 center
- Integral Healthcare — Adelaide
Austria · 1 center
- Kepler Universitätsklinikum GmbH — Linz
Latvia · 1 center
- Pauls Stradins Clinical University Hospital — Riga
New Zealand · 1 center
- Auckland City Hospital — Grafton
Identifiers
NCT: NCT07393009 · BA118