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BIO|STREAM.CSP Study

Recruitingn/aAges 18 Years - anyAllBiotronik SE & Co. KG
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Implantation of the Solia CSP S pacing lead for LBBAP
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Where

46 sites
Integral Healthcare
Adelaide, Australia
Northern Hospital
Melbourne, Australia
Kepler Universitätsklinikum GmbH
Linz, Austria
Fakultní nemocnice Olomouc
Olomouc, Czechia
FN Kralovske Vinohrady
Prague, Czechia
Hôpital Gabriel Montpied
Clermont-Ferrand, France
Hôpital de la Timone
Marseille, France
Centre Hospitalier Metz-Thionville
Metz, France

…and 38 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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