BIO|MASTER.CSP Study

Last updated: October 28, 2024
Sponsor: Biotronik SE & Co. KG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Hyponatremia

Low Blood Pressure (Hypotension)

Treatment

Implantation of the Solia CSP S pacing lead for LBBAP

Clinical Study ID

NCT06620237
BA113
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment:

  • Standard indication for de novo pacemaker implantation or cardiac resynchronizationtherapy (CRT)

  • Patient is intended for implantation of a pacemaker or CRT-P system with left bundlebranch area stimulation

  • Ability to understand the nature of the study

  • Ability and willingness to perform all follow-up visits at the study site

  • Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIKHome Monitoring concept

Exclusion

Exclusion Criteria:

Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled:

  • Planned cardiac surgical procedures or interventional measures other than the studyprocedure within the next 12 months

  • Expected to receive heart transplantation or ventricular assist device within 12months

  • Life-expectancy less than 12 months

  • Pregnant or breast feeding

  • Age less than 18 years

  • Participation in another interventional clinical investigation (according to thedefinition given in the CIP)

Study Design

Total Participants: 152
Treatment Group(s): 1
Primary Treatment: Implantation of the Solia CSP S pacing lead for LBBAP
Phase:
Study Start date:
October 04, 2024
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Auckland City Hospital

    Auckland,
    New Zealand

    Active - Recruiting

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