BIO|MASTER.CSP Study

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Apr 2026 → Oct 2026
See other at-risk trials from Biotronik SE & Co. KG

Record History

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  1. Lead sponsor: Biotronik SE & Co. KG to Biotronik SE & Co. KG
    • Primary completion pushed from Apr 2026 to Oct 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 1 to 14
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2024 to Oct 4, 2024
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06620237
Lead Sponsor Biotronik SE & Co. KG
Conditions
(from sponsor)		 Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia, Conduction Disorder, Conduction Defect, Cardiac, Heart Failure
Related terms Arrhythmias, Cardiac, Bradycardia, Cardiac Conduction System Disease, Heart Failure
Enrollment 152 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov