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Life sciences · Observational Study
ClinicalTrials.gov · October 13, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT07393009). This is a study registration, not published results. Lead sponsor: Biotronik SE & Co. KG. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices, Bradycardia, Tachycardia, Heart Failure. Interventions: DEVICE: Implantation of the Solia CSP S pacing lead for LBBAP. Primary outcome measures: SADE-d free rate related to any investigatonal device , throughout study duration, average of 4 years; annual evaluations; Rate of successful acute implantation in LBBAP using investigational devices in LBBAP , Day 1; Capture type at implantation , Day 1; Long-term maintenance of LBBAP , throughout study duration, average of 4 years; annual evaluations; Electrical parameters - pacing threshold , throughout study duration, average of 4 years; annual evaluations; Electrical parameters - sensing amplitude , throughout study duration, average of 4 years; annual evaluations; Electrical parameters - pacing impedance , throughout study duration, average of 4 years; annual evaluations. Brief 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.