BIOTRONIK CSP Lead Registry for Left Bundle Branch Area Pacing

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 observational registry collects long-term data on BIOTRONIK devices used for conduction system pacing, focusing on performance, outcomes, and safety in a real-world setting. It involves de novo or recently implanted LBBAP with an investigational generator and lead, and follows patients through standard follow-up using CardioMessenger and BIOTRONIK Home Monitoring. The study emphasizes unselected clinical practice rather than a controlled trial, aiming to understand how these devices perform over time. Primary endpoints include device performance, lead safety, and patient outcomes in the context of CSP-based therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Guideline indication for pacemaker or cardiac resynchronization therapy with or without defibrillation function (CRT-P/-D)
* Patient is intended for a de novo implantation and LBBAP therapy with an investigational generator and an investigational lead OR has just been implanted with an investigational generator and an investigational lead positioned permanently deep within the intraventricular septum and has not yet been discharged from the hospital OR transitions from the BIO\|MASTER.CSP study
* Ability to understand the nature of the study
* Ability and willingness to perform all follow-up visits
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept

Exclusion Criteria:

* Planned dation from intended use
* Planned for cardiac surgical procedures, heart transplantation or interventional measures other than the study procedure within one year after enrollment
* Life-expectancy less than 12 months
* Pregnant or breast feeding
* Age less than 18 years
* Participation in an interventional clinical investigation, except for submodules within this study.

Where it's running

• Kepler Universitätsklinikum GmbH
  Linz, Austria Recruiting
• Fakultní nemocnice Olomouc
  Olomouc, Czechia Recruiting
• FN Kralovske Vinohrady
  Prague, Czechia Recruiting
• Hôpital Gabriel Montpied
  Clermont-Ferrand, France Recruiting
• Hôpital privé du Confluent
  Nantes, France Recruiting
• Krankenhaus Porz am Rhein gGmbH
  Cologne, Germany Recruiting

Study contacts

• Study coordinator: Johannes Pfaffenberger
• Email: csp-stream@biotronik.com
• Phone: +493068905

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Upper-extremity exercise options for people with heart failure and implanted devices

  This study tests different upper-extremity exercise programs to see which helps people with heart failure and implanted defibrillators or CRT devices improve arm function.

  Recruiting Erol Olcok Corum Training and Research Hospital · Çorum · NCT07592494

• Personalized pacemaker rate setting to improve symptoms in heart failure with bradycardia

  Researchers will try adjusting the pacemaker lower rate to a personalized, hemodynamically optimized heart rate to see if it reduces symptoms in people with heart failure who need a pacemaker.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07563153

• Sedation with dexmedetomidine, propofol, or both during cataract surgery

  This project will test whether dexmedetomidine, propofol, or their combination (each given with fentanyl) provides the best sedation, safety, and surgeon satisfaction for adults having cataract surgery.

  Recruiting Saint-Joseph University · Beirut · NCT07556133

• HeartBeam ECG Registry: See How Heartbeat Patterns Look Across People

  This registry tests HeartBeam ECG recordings in real-world patients to build a de-identified database for research.

  Recruiting HeartBeam, Inc. · Pittsburgh, Pennsylvania · NCT07501299

• Leadless Conduction System Pacemaker for Chronic Bradycardia

  This study tests a leadless AVEIR CSP pacemaker to see if it safely and reliably keeps heart rhythm in adults who need a pacemaker.

  Recruiting Abbott Medical Devices · Prague · NCT07287423

• Left bundle branch area pacing with Tendril STS or UltiPace leads

  This study will try left bundle branch area pacing with the Tendril STS or UltiPace lead in adults who need pacemaker leads for bradycardia or related heart conditions to see if pacing and sensing are safe and work through six months after implant.

  Recruiting at 13 sites Abbott Medical Devices · Rio de Janeiro, Rio de Janeiro and 14 other locations · NCT07217392

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.