BIO|STREAM.CSP CLS

Recruiting now

Conditions studied: Sinus Node Disease, Atrioventricular Block

In brief

This clinical study is a prospective, observational submodule of the BIO\|STREAM.CSP registry designed to evaluate clinical outcomes in patients receiving BIOTRONIK dual-chamber pacemakers that combine conduction system pacing-specifically left bundle branch area pacing (LBBAP)-with Closed Loop Stimulation (CLS). The purpose of the study is to better understand how this combined pacing strategy performs in routine clinical practice and whether it may help reduce the occurrence of atrial fibrillation in patients with sinus node dysfunction (SND) and concomitant atrioventricular (AV) conduction disorders. The primary question the study seeks to answer is what the incidence of device-detected atrial fibrillation (DDAF) is over a 24-month follow-up period in patients treated with LBBAP and active CLS. Additionally, the study explores how CLS dynamically modulates pacing rates when the ventricular lead is positioned within the conduction system, and whether this physiological pacing approach may mitigate the negative effects associated with conventional right ventricular pacing. Overall, this study aims to generate real-world evidence to support optimization of pacemaker programming and to inform clinical decision-making regarding the use of CLS in combination with conduction system pacing, with the goal of improving patient outcomes and reducing atrial arrhythmia burden.

Key facts

Study ID

NCT07608822

Run by

Biotronik SE & Co. KG

People needed

150

Starts

2026-05-29

Expected to finish

2030-05-29

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in the BIO\|STREAM.CSP registry
• Standard indication for dual-chamber pacing due to any form of sinus node disease according to guidelines
• DDD-CLS pacing mode activated
• Either ≥ II degree AV block, or native PR interval ≥ 200 ms at baseline ECG with expected RVP ≥ 20%

You may not qualify if…

• Implantation dates back more than 90 days
• History of clinical AF
• Patients intended to receive, or already received a pacing lead for traditional RV pacing, His bundle pacing or right bundle branch pacing
• Upgrade from previous pacemaker system
• Patients transitioning from the BIO\|MASTER.CSP study
• DDAF episodes present in the device memory at the time of registration

Where it is running

• A.O.U. Maggiore della Carita di Novara — Novara, Italy (enrolling)
• Semmelweis University — Budapest, Hungary
• University of Szeged — Szeged, Hungary
• Ospedale Di Summa - Perrino — Brindisi, Italy
• Niguarda hospital — Milan, 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
• Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra — Coimbra, Portugal
• Hospital Universitario 12 de Octubre — Madrid, Spain
• Masarykova nemocnice v Usti nad Labem — Ústí nad Labem, Czechia
• Hospital Universitario La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.