No phaseActive, not recruiting
BIO|MASTER.CSP Study
Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing
- Sponsor
- Biotronik SE & Co. KG (Industry)
- Enrolment
- 152 planned
- Conditions
- Cardiac Pacing, Artificial; Cardiac Pacemaker, Artificial; Cardiac Resynchronization Therapy Devices; Bradycardia; Conduction Disorder; Conduction Defect, Cardiac; Heart Failure
- Interventions
- Implantation of the Solia CSP S pacing lead for LBBAP
- Ages
- adults, older adults
- Registry
- NCT06620237
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Amvia related SADE-d free rate
- Solia CSP S related SADE-d free rate
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered