BIO|MASTER.CSP Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Implantation of the Solia CSP S pacing lead for LBBAP: Left bundle branch area pacing using a Solia CSP S lead

Study summary

The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs.

The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.

Eligibility

Primary outcome measure(s)

• Amvia related SADE-d free rate — 6 months (183 days) after implantation
  rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker
• Solia CSP S related SADE-d free rate — 6 months (183 days) after implantation
  rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead

Trial sites (14)

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