RecruitingNCT07393009

BIO|STREAM.CSP Study

Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP)

Sponsor

Biotronik SE & Co. KG

Enrollment

1,000 participants

Start Date

May 25, 2026

Study Type

OBSERVATIONAL

Conditions

Heart Failure Cardiac Pacing Implantable Cardioverter Defibrillator Bradycardia Tachycardia Cardiac Pacemaker Cardiac Resynchronization Therapy Devices

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Implantation of the Solia CSP S pacing lead for LBBAP for people with bradycardia, cardiac pacemaker, and other related conditions. The study is currently recruiting participants at 40 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEImplantation 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)

Locations(40)

Integral Healthcare

Adelaide, 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

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

Central Hospital of Northern Pest - Military Hospital

Budapest, Hungary

Semmelweis University

Budapest, Hungary

University of Pécs

Pécs, 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

A.O.U. Maggiore della Carita di Novara

Novara, Italy

Ospedale di Piove di Sacco

Piove di Sacco, Italy

Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore

Roma, Italy

SS Annunziata Taranto

Taranto, Italy

Pauls Stradins Clinical University Hospital

Riga, Latvia

Auckland City Hospital

Grafton, New Zealand

Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra

Coimbra, Portugal

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 Universitari Germans Trias i Pujol

Barcelona, Spain

Hospital La Luz

Madrid, Spain

Hospital Universitario 12 de Octubre

Valencia, Spain

Hospital Universitario La Fe

Valencia, Spain

Inselspital, Universitätsspital Bern

Bern, Switzerland

Universitätsspital Zürich (USZ)

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07393009

Related Trials

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

NCT06024746104 locations

Staged Kidney Transplantation During Combined Heart/Kidney Transplantation

NCT068771691 location

iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases

NCT0354975476 locations

"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)

NCT0581574545 locations

Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)

NCT071132235 locations