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BIO|STREAM.CSP CLS

16 lipca 2026 zaktualizowane przez: Biotronik SE & Co. KG

Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing (CSP) With Focus on Closed Loop Stimulation (CLS)

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Urządzenie: Left bundle branch area pacing with Closed Loop Stimulation

Szczegółowy opis

This study, BIO|STREAM.CSP CLS, is a prospective, observational submodule of the ongoing BIO|STREAM.CSP registry. It is designed to collect real-world clinical data from patients who receive BIOTRONIK dual-chamber pacemakers using conduction system pacing (CSP), with a specific focus on the combination of left bundle branch area pacing (LBBAP) and Closed Loop Stimulation (CLS).

Permanent cardiac pacing is a standard therapy for patients with sinus node dysfunction (SND), a condition in which the heart's natural pacemaker does not function properly. A considerable proportion of these patients also have atrioventricular (AV) conduction disorders, which impair the electrical connection between the atria and ventricles. In such cases, dual-chamber pacemakers are typically implanted to maintain appropriate heart rhythm and coordination.

Traditional right ventricular (RV) pacing, while effective in maintaining heart rate, has been associated with non-physiological activation of the heart and may contribute to an increased risk of atrial fibrillation (AF), especially when pacing burden is high. Device-detected atrial fibrillation (DDAF) is a clinically relevant outcome, as it is associated with increased risk of stroke, heart failure, and other cardiovascular complications.

Closed Loop Stimulation (CLS) is an advanced pacemaker feature designed to provide more physiological heart rate adaptation by continuously monitoring cardiac contractility and adjusting the pacing rate accordingly. In previous studies, including the B3 trial, CLS demonstrated a reduction in DDAF incidence in patients with SND. However, this benefit was not observed in patients with AV block, likely due to the adverse effects of frequent RV pacing.

Conduction system pacing, and in particular left bundle branch area pacing (LBBAP), is an emerging pacing strategy that stimulates the heart's intrinsic conduction pathways, resulting in a more physiological and synchronized ventricular activation. This approach has the potential to reduce the negative effects associated with RV pacing.

The BIO|STREAM.CSP CLS submodule aims to investigate whether the combination of LBBAP and CLS can reduce the incidence of DDAF in patients with both SND and AV conduction disorders in routine clinical practice. The study will follow approximately 150 patients over a 24-month period after pacemaker implantation. Patients included are those enrolled in the BIO|STREAM.CSP registry who receive a de novo dual-chamber pacemaker with activated CLS and LBBAP, and who have no prior history of atrial fibrillation.

The primary objective of this exploratory submodule is to assess the incidence and timing of DDAF episodes following activation of CLS, using device-based diagnostics over the follow-up period. The study will evaluate multiple thresholds of AF episode duration (e.g., ≥6 minutes, ≥6 hours, ≥24 hours, and ≥7 days), as well as the time to first occurrence and overall AF burden. Secondary analyses will explore how CLS modulates heart rate in patients with conduction system pacing, including the distribution of paced and sensed heart rates over time.

As an observational study without a control group, BIO|STREAM.CSP CLS is intended to generate hypothesis-generating, real-world evidence rather than to test a predefined hypothesis. The findings are expected to provide insights into the clinical performance of CLS in combination with LBBAP and to support optimization of device programming strategies.

Overall, this study seeks to improve understanding of how advanced pacing technologies can be used together to deliver more physiological cardiac pacing, with the goal of reducing atrial arrhythmias and improving long-term outcomes in patients requiring permanent pacemakers.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

150

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: Martina Del Maestro
Numer telefonu: +393426529214
E-mail: CLS-CSP-STREAM@biotronik.com

Kopia zapasowa kontaktu do badania

Nazwa: Paola Napoli
Numer telefonu: +393357369277
E-mail: CLS-CSP-STREAM@biotronik.com

Lokalizacje studiów

Czechy
- - Ústí nad Labem, Czechy
    - Jeszcze nie rekrutacja
    - Masarykova Nemocnice V Usti Nad Labem
    - Kontakt:
      
      Jíří Holý
      
      E-mail: jiri.holy@kzcr.eu
Hiszpania
- - Madrid, Hiszpania
    - Jeszcze nie rekrutacja
    - Hospital Universitario 12 de Octubre
    - Kontakt:
      
      Alvaro Marco del Castillo
      
      E-mail: amarco89@hotmail.com
  - Valencia, Hiszpania
    - Jeszcze nie rekrutacja
    - Hospital Universitario La Fe
    - Kontakt:
      
      Óscar Cano Pérez
      
      E-mail: cano_osc@gva.es
Portugalia
- - Coimbra, Portugalia
    - Jeszcze nie rekrutacja
    - Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra
    - Kontakt:
      
      E-mail: joaoaferreira29@gmail.com
    - Kontakt:
      
      João Ferreira
Węgry
- - Budapest, Węgry
    - Jeszcze nie rekrutacja
    - Semmelweis University
    - Kontakt:
      
      László Gellér
      
      E-mail: geller.laszlo@kardio.sote.hu
  - Szeged, Węgry
    - Jeszcze nie rekrutacja
    - University Of Szeged
    - Kontakt:
      
      Tamás Szili-Török
      
      E-mail: szili-torok.tamas@u-szeged.hu
Włochy
- - Brindisi, Włochy
    - Jeszcze nie rekrutacja
    - Ospedale Di Summa - Perrino
    - Kontakt:
      
      Ennio CL Pisanò
      
      E-mail: enniopisano@hotmail.com
  - Milan, Włochy
    - Jeszcze nie rekrutacja
    - Niguarda Hospital
    - Kontakt:
      
      Matteo Baroni
      
      E-mail: bimatteo@gmail.com
  - Novara, Włochy
    - Rekrutacyjny
    - A.O.U. Maggiore della Carita di Novara
    - Kontakt:
      
      Gabriele Dell'Era
      
      Numer telefonu: +3903213731
      
      E-mail: gdellera@gmail.com
  - Piove di Sacco, Włochy
    - Jeszcze nie rekrutacja
    - Ospedale di Piove di Sacco
    - Kontakt:
      
      Leonardo Marinaccio
      
      E-mail: leonardo.marinaccio@aulss6.veneto.it
  - Roma, Włochy
    - Jeszcze nie rekrutacja
    - Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore
    - Kontakt:
      
      Maria Lucia Narducci
      
      E-mail: marialucia.narducci@policlinicogemelli.it
  - Taranto, Włochy
    - Jeszcze nie rekrutacja
    - SS Annunziata Taranto
    - Kontakt:
      
      Cosimo Mandurino
      
      Numer telefonu: +390994585111
      
      E-mail: mandurinocosimo@gmail.com

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

Dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

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%

Exclusion Criteria:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
DDAF incidence Ramy czasowe: 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	From CLS activation to 24 months after implantation
DDAF burden Ramy czasowe: 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	From CLS activation to 24 months after implantation
Heart Rate histograms Ramy czasowe: 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	At 1 year and 2 years after implantation

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Biotronik SE & Co. KG

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 maja 2026

Zakończenie podstawowe (Szacowany)

29 maja 2028

Ukończenie studiów (Szacowany)

29 maja 2030

Daty rejestracji na studia

Pierwszy przesłany

20 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości