Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

BIO|STREAM.CSP CLS

16 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

150

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Espagne
      • Madrid, Espagne
        • Pas encore de recrutement
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Valencia, Espagne
        • Pas encore de recrutement
        • Hospital Universitario La Fe
        • Contact:
  • Hongrie
  • Italie
      • Brindisi, Italie
      • Milan, Italie
        • Pas encore de recrutement
        • Niguarda Hospital
        • Contact:
      • Novara, Italie
        • Recrutement
        • A.O.U. Maggiore della Carita di Novara
        • Contact:
      • Piove di Sacco, Italie
      • Roma, Italie
      • Taranto, Italie
        • Pas encore de recrutement
        • SS Annunziata Taranto
        • Contact:
  • Le Portugal
      • Coimbra, Le Portugal
        • Pas encore de recrutement
        • Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra
        • Contact:
        • Contact:
          • João Ferreira
  • Tchéquie
      • Ústí nad Labem, Tchéquie
        • Pas encore de recrutement
        • Masarykova Nemocnice V Usti Nad Labem
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
DDAF incidence
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Biotronik SE & Co. KG

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 mai 2026

Achèvement primaire (Estimé)

29 mai 2028

Achèvement de l'étude (Estimé)

29 mai 2030

Dates d'inscription aux études

Première soumission

20 mai 2026

Première soumission répondant aux critères de contrôle qualité

20 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 juillet 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BA121

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner