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
The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.
Other
Prospective
Implantation of the Solia CSP S pacing lead for LBBAP
DeviceObservation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (CSP)
SADE-d free rate related to any investigatonal device
Rate of serious adverse device effects possible, probable or causal related to any investigational device.
Rate of successful acute implantation in LBBAP using investigational devices in LBBAP
All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently deep within the intraventricular septum are counted as acute success.
Capture type at implantation
The investigator confirms the type of pacing capture for any implantation in which the pacing lead is permanently positioned deep within the interventricular septum. Success rates for LBBAP and CSP are determined based on ECG parameters.
Long-term maintenance of LBBAP
The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording.
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