BIO|STREAM.CSP CLS
NCT: NCT07608822 · NOT_YET_RECRUITING
Brief Summary
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.
Frequently Asked Questions
What is BIO|STREAM.CSP CLS?
BIO|STREAM.CSP CLS is a clinical trial registered under NCT07608822. Current status: NOT_YET_RECRUITING.
What is the status of NCT07608822?
The current status of NCT07608822 (BIO|STREAM.CSP CLS) is: NOT_YET_RECRUITING.
When did BIO|STREAM.CSP CLS start?
BIO|STREAM.CSP CLS started on 2026-05-29.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.