BIO|MASTER.CSP Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Bradycardia; Cardiac Pacemaker, Artificial; Cardiac Pacing, Artificial; Cardiac Resynchronization Therapy Devices; Conduction Disorder; Conduction Defect, Cardiac
• Intervention / Treatment: Device: Implantation of the Solia CSP S pacing lead for LBBAP

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5068
    • Integral Healthcare
  • Clayton, Australia, 3168
    • Victorian Heart Hospital
  • Elizabeth Vale, Australia, 5112
    • Lyell McEwin Hospital
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint-Jan
  • Charleroi, Belgium, 6060
    • Grand Hôpital de Charleroi
  • Ghent, Belgium, 9000
    • UZ Gent - Universitair Ziekenhuis Gent
  • Ottignies, Belgium, 1340
    • Clinique Saint-Pierre Ottignies
• France
  • Marseille, France, 13005
    • Hopital de la Timone (CHU La Timone)
  • Metz, France, 57038
    • Centre Hospitalier Metz-Thionville
  • Nantes, France, 44277
    • Hôpital Privé du Confluent
  • Pessac, France, 33600
    • Hôpital Haut Lévêque (CHU)
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Noordwest Ziekenhuisgroep
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
• New Zealand
  • Grafton, New Zealand, 1023
    • Auckland City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: LBBAP Amvia; All patients with successful implantation of Amvia pacemaker and a lead in a position intended for LBBA pacing.
Experimental: LBBAP Solia CSP S; All patients with successful implantation of a Solia CSP S lead in LBB area. Additionally, all patients with a non-successful Solia CSP S implantation attempt in which an ADE (adverse device effect) or SADE (serious adverse device effect) related to the Solia CSP S lead occurred.	Device: Implantation of the Solia CSP S pacing lead for LBBAP; Left bundle branch area pacing using a Solia CSP S lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amvia related SADE-d free rate	rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker	6 months (183 days) after implantation
Solia CSP S related SADE-d free rate	rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead	6 months (183 days) after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amvia related SADE-d free rate	Rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker	12 months (365 days) after implantation
Solia CSP S related SADE-d free rate	Rate of serious adverse device effects possible, probable or causal related to the Solia CSP S lead	12 months (365 days) after implantation
Rate of successful acute CSP implantation of Solia CSP S	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.	At the day of implantation
Sensing performance	Investigators will be asked whether the sensing is adequate (yes/no decision)	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
Pacing performance	Investigators will be asked whether the pacing is adequate (yes/no decision)	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
Physiologic ventricular excitation	Investigators are asked to assess whether pacing in the left bundle branch area is still present based on the 12-lead ECG recording	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
Mid-term change in LVEF	Collection of left ventricular ejection fraction (LVEF) values	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
Mid-term change in LVESV	Collection of left ventricular ejection systolic volume (LVESV) values	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
Mid-term change in quality of life, EQ-5D-5L (EuroQol) questionnaire	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	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
Mid-term change in quality of life, SF-36 (Short Form Health Survey) questionnaire	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	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

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG
• Investigators: Study Chair: Jan De Pooter, MD, PhD, University Hospital Ghent, Gent (Belgium)

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Conduction system pacing (CSP); Left bundle branch area pacing (LBBAP)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Heart Failure; Bradycardia; Arrhythmias, Cardiac
• Other Study ID Numbers: BA113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data may be shared with qualified healthcare practitioners or academic researchers upon request and with permission of BIOTRONIK. Requests shall be sent to the Clinical Research Department of BIOTRONIK.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No