An observational study in Cardiac Pacing, Cardiac Pacemaker and Implantable Cardioverter Defibrillator, sponsored by Biotronik SE & Co. KG. Recruiting at 46 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Biotronik SE & Co. KG · Observational
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patient population consists exclusively of patients with an indication for pacemaker or cardiac resynchronization therapy according to the current clinical practice.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Observation 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.
Time frame: throughout study duration, average of 4 years; annual evaluations
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.
Time frame: Day 1
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.
Time frame: Day 1
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.
Time frame: throughout study duration, average of 4 years; annual evaluations
Electrical parameters - pacing threshold
The investigators will be asked to record the pacing thresholds (Volts) of the LBBAP leads at a pulse width of 0.4 ms.
Time frame: throughout study duration, average of 4 years; annual evaluations
Electrical parameters - sensing amplitude
The investigators will be asked to record the sensing amplitude (Millivolts) of the LBBAP leads.
Time frame: throughout study duration, average of 4 years; annual evaluations
Electrical parameters - pacing impedance
The investigators will be asked to record the lead pacing impedance (Ohms) of the LBBAP leads.
Time frame: throughout study duration, average of 4 years; annual evaluations
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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