Left bundle area pacing with Closed Loop Stimulation in dual‑chamber pacemakers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational submodule of the BIO|STREAM.CSP registry. It collects real‑world data on BIOTRONIK dual‑chamber pacemakers that use left bundle area pacing in combination with Closed Loop Stimulation. The study looks at the incidence of device‑detected atrial fibrillation over 24 months and how CLS adjusts pacing rates when the ventricular lead sits in the conduction system. It also aims to characterize the physiological pacing behavior and safety in routine clinical practice. Eligible patients have sinus node disease with AV conduction disorders and meet standard dual‑chamber pacing indications.

Why it matters

Who can join: the full rules

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

Where it's running

• A.O.U. Maggiore della Carita di Novara
  Novara, Italy Recruiting
• Masarykova nemocnice v Usti nad Labem
  Ústí nad Labem, Czechia Not yet recruiting
• Semmelweis University
  Budapest, Hungary Not yet recruiting
• University of Szeged
  Szeged, Hungary Not yet recruiting
• Ospedale Di Summa - Perrino
  Brindisi, Italy Not yet recruiting
• Niguarda hospital
  Milan, Italy Not yet recruiting

Study contacts

• Study coordinator: Martina Del Maestro
• Email: CLS-CSP-STREAM@biotronik.com
• Phone: +393426529214

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.