🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

BIO|STREAM.CSP CLS

Recruitingn/aAges 18 Years - 18 YearsAllBiotronik SE & Co. KG
NCT07608822 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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 ventr

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • Left bundle branch area pacing with Closed Loop Stimulation
📍

Where

12 sites
Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, Czechia
Semmelweis University
Budapest, Hungary
University of Szeged
Szeged, Hungary
Ospedale Di Summa - Perrino
Brindisi, Italy
Niguarda hospital
Milan, Italy
A.O.U. Maggiore della Carita di Novara
Novara, Italy
Ospedale di Piove di Sacco
Piove di Sacco, Italy
Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore
Roma, Italy

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy