| NCT ID | NCT07608822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biotronik SE & Co. KG |
| Condition | Sinus Node Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-29 |
| Primary Completion | 2028-05-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-05-29 with a primary completion date of 2028-05-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07608822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 18 Years, studying Sinus Node Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07608822 currently recruiting?
Yes, NCT07608822 is actively recruiting participants. Contact the research team at CLS-CSP-STREAM@biotronik.com for enrollment information.
Where is the NCT07608822 trial being conducted?
This trial is being conducted at Ústí nad Labem, Czechia, Budapest, Hungary, Szeged, Hungary, Brindisi, Italy and 8 additional locations.
Who is sponsoring the NCT07608822 clinical trial?
NCT07608822 is sponsored by Biotronik SE & Co. KG. The trial plans to enroll 150 participants.