BIO|MASTER.CSP Study

NCT ID: NCT06620237

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-04
• Study Completion Date: 2027-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LBBAP Amvia

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Implantation of the Solia CSP S pacing lead for LBBAP

Intervention Type: DEVICE

Left bundle branch area pacing using a Solia CSP S lead

Interventions

Implantation of the Solia CSP S pacing lead for LBBAP

Left bundle branch area pacing using a Solia CSP S lead

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan De Pooter, MD, PhD

Role: STUDY_CHAIR

University Hospital Ghent, Gent (Belgium)

Locations

Integral Healthcare

Adelaide, , Australia

Victorian Heart Hospital

Clayton, , Australia

Lyell McEwin Hospital

Elizabeth Vale, , Australia

AZ Sint-Jan

Bruges, , Belgium

Grand Hôpital de Charleroi

Charleroi, , Belgium

UZ Gent - Universitair Ziekenhuis Gent

Ghent, , Belgium

Clinique Saint-Pierre Ottignies

Ottignies, , Belgium

Hopital de la Timone (CHU La Timone)

Marseille, , France

Centre Hospitalier Metz-Thionville

Metz, , France

Hôpital privé du Confluent

Nantes, , France

Hôpital Haut Lévêque (CHU)

Pessac, , France

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Auckland City Hospital

Grafton, , New Zealand

Countries

Australia; Belgium; France; Netherlands; New Zealand

Other Identifiers

BA113

Identifier Type: -

Identifier Source: org_study_id