The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
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
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
Biotronik SE & Co. KG
Lead sponsor