Actively Recruiting
Observation of Clinical Routine Care for Patients Implanted With BIOTRONIK Devices Used for Conduction System Pacing With Focus on Closed Loop Stimulation
Led by Biotronik SE & Co. KG · Updated on 2026-06-02
150
Participants Needed
12
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical outcomes of patients with sinus node dysfunction (SND) and atrioventricular (AV) conduction disorders who receive BIOTRONIK dual-chamber pacemakers using left bundle branch area pacing (LBBAP) combined with Closed Loop Stimulation (CLS). This observational study aims to better understand how this combined pacing strategy performs in routine practice and whether it may reduce device-detected atrial fibrillation (DDAF) over a 24-month follow-up. The study explores whether this physiological pacing approach can lessen the negative effects linked to conventional right ventricular pacing in these patients. Participants receive a dual-chamber pacemaker with the ventricular lead positioned in the left bundle branch area and have the CLS rate-responsive algorithm activated. The study follows about 150 patients enrolled in the BIO|STREAM.CSP registry who receive this device as a new implant and have no prior history of atrial fibrillation. There is no control group as it is an observational study, focusing on real-world use of this combined pacing method over two years. Throughout the study, researchers monitor device-detected atrial fibrillation incidence and burden from the time CLS is activated up to 24 months after implantation. They also analyze heart rate histograms at one and two years to understand how CLS modulates pacing rates with conduction system pacing. The study collects clinical data to support optimization of pacemaker programming and improve long-term patient outcomes by reducing atrial arrhythmia burden.
CONDITIONS
Brief Title
BIO|STREAM.CSP CLS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in the BIO|STREAM.CSP registry
- Standard indication for dual-chamber pacing due to sinus node disease according to guidelines
- DDD-CLS pacing mode activated
- Either at least second-degree AV block or native PR interval of 200 ms or more at baseline ECG with expected right ventricular pacing of 20% or more
You will not qualify if you...
- Implantation older than 90 days
- History of clinical atrial fibrillation
- Patients intended to receive or already received pacing leads for traditional right ventricular pacing, His bundle pacing, or right bundle branch pacing
- Upgrade from previous pacemaker system
- Patients transitioning from the BIO|MASTER.CSP study
- Device-detected atrial fibrillation episodes present in device memory at registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days before enrollment
Participants receive 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 as part of routine clinical care.
1 implantation visit (in-person)
Duration - 24 months
Participants who undergo routine care are observed for device-detected atrial fibrillation incidence, burden, and heart rate patterns using device diagnostics over the 24 months following pacemaker implantation.
Regular follow-up visits as per clinical routine over 24 months
Trial Site Locations
Total: 12 locations
1
Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, Czechia
Not Yet Recruiting
2
Semmelweis University
Budapest, Hungary
Not Yet Recruiting
3
University of Szeged
Szeged, Hungary
Not Yet Recruiting
4
Ospedale Di Summa - Perrino
Brindisi, Italy
Not Yet Recruiting
5
Niguarda hospital
Milan, Italy
Not Yet Recruiting
6
A.O.U. Maggiore della Carita di Novara
Novara, Italy
Actively Recruiting
7
Ospedale di Piove di Sacco
Piove di Sacco, Italy
Not Yet Recruiting
8
Fondazione Policlinico Universitario "Agostino Gemelli" Università Cattolica del Sacro Cuore
Roma, Italy
Not Yet Recruiting
9
SS Annunziata Taranto
Taranto, Italy
Not Yet Recruiting
10
Unidade local de Saúde de Coimbra, EPE - Centro Hospitalar Universitario de Coimbra
Coimbra, Portugal
Not Yet Recruiting
11
Hospital Universitario 12 de Octubre
Madrid, Spain
Not Yet Recruiting
12
Hospital Universitario La Fe
Valencia, Spain
Not Yet Recruiting
Research Team
M
Martina Del Maestro
P
Paola Napoli
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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