Condition: Sinus Node Disease · Atrioventricular Block · Sponsor: Biotronik SE & Co. KG
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.
This description comes directly from the study's public registry record.
Martina Del Maestro · +393426529214 · CLS-CSP-STREAM@biotronik.com
Paola Napoli · +393357369277 · CLS-CSP-STREAM@biotronik.com
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| Masarykova nemocnice v Usti nad Labem | Ústí nad Labem, Czechia | Not Yet Recruiting |
| Semmelweis University | Budapest, Hungary | Not Yet Recruiting |
| University of Szeged | Szeged, Hungary | Not Yet Recruiting |
| Ospedale Di Summa - Perrino | Brindisi, Italy | Not Yet Recruiting |
| Niguarda hospital | Milan, Italy | Not Yet Recruiting |
| A.O.U. Maggiore della Carita di Novara | Novara, Italy | Recruiting |
| Ospedale di Piove di Sacco | Piove di Sacco, Italy | Not Yet Recruiting |
| Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore | Roma, Italy | Not Yet Recruiting |
| SS Annunziata Taranto | Taranto, Italy | Not Yet Recruiting |
| Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra | Coimbra, Portugal | Not Yet Recruiting |
| Hospital Universitario 12 de Octubre | Madrid, Spain | Not Yet Recruiting |
| Hospital Universitario La Fe | Valencia, Spain | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07608822