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BIO|STREAM.CSP CLS

NCT07608822 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-05-27

No results posted yet for this 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.

Conditions

  • Sinus Node Disease
  • Atrioventricular Block

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2028-05-29
Completion
2030-05-29

Countries

  • Czechia
  • Hungary
  • Italy
  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608822 on ClinicalTrials.gov