BIO|STREAM.CSP Study

Summary

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.

Eligibility

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.

Conditions8

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