Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06620237

BIO|MASTER.CSP Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Pacing, Artificial Arrhythmias, Cardiac Bradycardia Cardiac Conduction System Disease Cardiac Pacemaker, Artificial Cardiac Resynchronization Therapy Devices Cardiovascular Diseases Conduction Defect, Cardiac Conduction Disorder Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integral Healthcare, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 resynchronization therapy (CRT)
  • Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch 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 BIOTRONIK Home Monitoring concept

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 study procedure within the next 12 months
  • Expected to receive heart transplantation or ventricular assist device within 12 months
  • Life-expectancy less than 12 months
  • Pregnant or breast feeding
  • Age less than 18 years
  • Participation in another interventional clinical investigation (according to the definition given in the CIP)

Treatment and study plan

Implantation of the Solia CSP S pacing lead for LBBAP

Device

Left bundle branch area pacing using a Solia CSP S lead

Primary outcomes

  1. Amvia related SADE-d free rate

    Time frame: 6 months (183 days) after implantation

    rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker

  2. Solia CSP S related SADE-d free rate

    Time frame: 6 months (183 days) after implantation

    rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead

Secondary outcomes

  1. Amvia related SADE-d free rate

    Time frame: 12 months (365 days) after implantation

    Rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker

  2. Solia CSP S related SADE-d free rate

    Time frame: 12 months (365 days) after implantation

    Rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead

  3. Rate of successful acute CSP implantation of Solia CSP S

    Time frame: At the day of implantation

    All implantations, in which the investigator decides to leave the Solia CSP S pacing lead permanently in the conduction system, are counted as acute success.

  4. Sensing performance

    Time frame: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section

    Investigators will be asked whether the sensing is adequate (yes/no decision)

  5. Pacing performance

    Time frame: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section

    Investigators will be asked whether the pacing is adequate (yes/no decision)

  6. Physiologic ventricular excitation

    Time frame: At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section

    Investigators are asked to assess whether pacing in the left bundle branch area is still present based on the 12-lead ECG recording

  7. Mid-term change in LVEF

    Time frame: At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section

    Collection of left ventricular ejection fraction (LVEF) values

  8. Mid-term change in LVESV

    Time frame: At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section

    Collection of left ventricular ejection systolic volume (LVESV) values

  9. Mid-term change in quality of life, EQ-5D-5L (EuroQol) questionnaire

    Time frame: At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section

    Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to EuroQol methodology

  10. Mid-term change in quality of life, SF-36 (Short Form Health Survey) questionnaire

    Time frame: At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section

    Collection of health-related quality of life questionnaires from the patient to monitor mid-term changes in the quality of life, analysis and reporting according to item short form health survey (SF-36) standard methodology

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.