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BIO|MASTER.CSP Study

NCT06620237 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-11-18

No results posted yet for this 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.

Conditions

  • Cardiac Pacing, Artificial
  • Cardiac Pacemaker, Artificial
  • Cardiac Resynchronization Therapy Devices
  • Bradycardia
  • Conduction Disorder
  • Conduction Defect, Cardiac
  • Heart Failure

Interventions

DEVICE

Implantation of the Solia CSP S pacing lead for LBBAP

Left bundle branch area pacing using a Solia CSP S lead

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Jan De Pooter, MD, PhD · University Hospital Ghent, Gent (Belgium)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2026-04-30
Completion
2027-09-30

Countries

  • Australia
  • Belgium
  • France
  • Netherlands
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620237 on ClinicalTrials.gov