BIO|MASTER.CSP Study

NCT06620237 | Active Not Recruiting

• 1 other identifier: BA113
• Study Type: interventional
• Target: 152
• Locations: 5 countries
• Sites: 14

Brief 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

Keywords

Conduction system pacing (CSP); Left bundle branch area pacing (LBBAP)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Amvia related SADE-d free rate

  12 months (365 days) after implantation

• Solia CSP S related SADE-d free rate

  12 months (365 days) after implantation

• Rate of successful acute CSP implantation of Solia CSP S

  At the day of implantation

• Sensing performance

  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

  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

Study Arms (2)

LBBAP Amvia

NO INTERVENTION

All patients with successful implantation of Amvia pacemaker and a lead in a position intended for LBBA pacing.

LBBAP Solia CSP S

EXPERIMENTAL

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

Interventions

Implantation of the Solia CSP S pacing lead for LBBAP DEVICE

Left bundle branch area pacing using a Solia CSP S lead

LBBAP Solia CSP S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (14)

Integral Healthcare

Adelaide, 5068, Australia

Location

Victorian Heart Hospital

Clayton, 3168, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, 5112, Australia

Location

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, 6060, Belgium

Location

UZ Gent - Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Clinique Saint-Pierre Ottignies

Ottignies, 1340, Belgium

Location

Hopital de la Timone (CHU La Timone)

Marseille, 13005, France

Location

Centre Hospitalier Metz-Thionville

Metz, 57038, France

Location

Hôpital privé du Confluent

Nantes, 44277, France

Location

Hôpital Haut Lévêque (CHU)

Pessac, 33600, France

Location

Noordwest Ziekenhuisgroep

Alkmaar, 1815 JD, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Auckland City Hospital

Grafton, 1023, New Zealand

Location

MeSH Terms

Conditions

Bradycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan De Pooter, MD, PhD

  University Hospital Ghent, Gent (Belgium)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: October 1, 2024
• Study Start: October 4, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); NL (2); NZ (1); BE (4); FR (4)