BIO|STREAM.CSP Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Implantation of the Solia CSP S pacing lead for LBBAP: Observation of clinical routine care for patients implanted with BIOTRONIK devices used for conduction system pacing (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

Primary outcome measure(s)

• SADE-d free rate related to any investigatonal device — throughout study duration, average of 4 years; annual evaluations
  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 — Day 1
  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 — Day 1
  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 — throughout study duration, average of 4 years; annual evaluations
  The investigator is asked to assess the effectiveness of LBBAP during follow-up based on the interpretation of a 12-lead ECG recording.
• Electrical parameters - pacing threshold — throughout study duration, average of 4 years; annual evaluations
  The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms.
• Electrical parameters - sensing amplitude — throughout study duration, average of 4 years; annual evaluations
  The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.
• Electrical parameters - pacing impedance — throughout study duration, average of 4 years; annual evaluations
  The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.

Trial sites (40)

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