BIO|STREAM.CSP CLS

Condition(s) studied

Investigational drug(s) / intervention(s)

Left bundle branch area pacing with Closed Loop Stimulation: Permanent dual-chamber cardiac pacing with ventricular lead placement in the left bundle branch area and activation of the Closed Loop Stimulation (CLS) rate-responsive algorithm.

Study 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.

Eligibility

Primary outcome measure(s)

• DDAF incidence — From CLS activation to 24 months after implantation
  Time from CLS activation to the first device-detected atrial fibrillation (DDAF) episode of different duration cutoffs (6 minutes, 6 hours, 24 hours, 7 days) through 24 months of follow-up after implantation
• DDAF burden — From CLS activation to 24 months after implantation
  The time from CLS activation to the first day with a DDAF burden ≥1% (≈15 minutes) determined within a follow-up period of 24 months after implantation
• Heart Rate histograms — At 1 year and 2 years after implantation
  Heart Rate histograms of sensed and paced beats \[% time\] at 1-year and 2-year follow-ups

Trial sites (12)

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