BIO|STREAM.CSP CLS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-18
SponsorBiotronik SE & Co. KG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Left bundle branch area pacing with Closed Loop Stimulation
DevicePermanent 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
From CLS activation to 24 months after implantation2
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
Time frame
From CLS activation to 24 months after implantation3
Heart Rate histograms
Heart Rate histograms of sensed and paced beats \[% time\] at 1-year and 2-year follow-ups
Time frame
At 1 year and 2 years after implantationSponsors and contacts
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Source ClinicalTrials.gov