BIO|STREAM.CSP CLS

NCT07608822 | Recruiting

• 1 other identifier: BA121
• Study Type: observational
• Target: 150
• Locations: 5 countries
• Sites: 12

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.

Conditions

Sinus Node Disease; Atrioventricular Block

Keywords

Conduction system pacing; Closed loop stimulation; Dual-chamber pacemaker; Left bundle branch area pacing

Outcome Measures

Primary Outcomes (3)

• DDAF incidence

  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

  From CLS activation to 24 months after implantation

• DDAF burden

  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

  From CLS activation to 24 months after implantation

• Heart Rate histograms

  Heart Rate histograms of sensed and paced beats \[% time\] at 1-year and 2-year follow-ups

  At 1 year and 2 years after implantation

Interventions

Left bundle branch area pacing with Closed Loop Stimulation DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for de novo dual-chamber pacing due to SND with evidence of AV conduction disorders, enrolled in the BIO\|STREAM.CSP registry.

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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (12)

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

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Martina Del Maestro

CONTACT

+393426529214; CLS-CSP-STREAM@biotronik.com

Paola Napoli

CONTACT

+393357369277; CLS-CSP-STREAM@biotronik.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): May 29, 2028
• Study Completion (Estimated): May 29, 2030
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

HU (2); IT (6); PT (1); ES (2); CZ (1)