Cardiac Pacing, ArtificialNCT06620237
BIO|MASTER.CSP Study
A study testing Implantation of the Solia CSP S pacing lead for LBBAP in people with Cardiac Pacing, Artificial and Cardiac Pacemaker, Artificial, run by Biotronik SE & Co. KG at 14 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices
- What is being tested?
- Implantation of the Solia CSP S pacing lead for LBBAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 4 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
Belgium4 sites
AZ Sint-Jan
Bruges, 8000
Grand Hôpital de Charleroi
Charleroi, 6060
UZ Gent - Universitair Ziekenhuis Gent
Ghent, 9000
Clinique Saint-Pierre Ottignies
Ottignies, 1340
France4 sites
Hopital de la Timone (CHU La Timone)
Marseille, 13005
Centre Hospitalier Metz-Thionville
Metz, 57038
Hôpital privé du Confluent
Nantes, 44277
Hôpital Haut Lévêque (CHU)
Pessac, 33600
Australia3 sites
Integral Healthcare
Adelaide, 5068
Victorian Heart Hospital
Clayton, 3168
Lyell McEwin Hospital
Elizabeth Vale, 5112
Netherlands2 sites
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD
Catharina Ziekenhuis
Eindhoven, 5623 EJ
About this study
Official title: 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.
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia, Conduction Disorder, Conduction Defect, Cardiac
- Being tested
- Implantation of the Solia CSP S pacing lead for LBBAP
- Keywords
- Conduction system pacing (CSP), Left bundle branch area pacing (LBBAP)
- Medical subject headings
- Bradycardia, Arrhythmias, Cardiac, Cardiac Conduction System Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the Solia CSP S pacing lead for LBBAPDevice
Left bundle branch area pacing using a Solia CSP S lead
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Implantation of the Solia CSP S pacing lead for LBBAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amvia related SADE-d free rate
rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker
Measured: 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
Measured: 6 months (183 days) after implantation
Secondary outcomes (10)
Amvia related SADE-d free rate
Rate of serious adverse device effects possible, probable or causal related to the Amvia pacemaker
Measured: 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
Measured: 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.
Measured: At the day of implantation
Sensing performance
Investigators will be asked whether the sensing is adequate (yes/no decision)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start4 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Pacing, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan De Pooter, MD, PhD, Study chair, University Hospital Ghent, Gent (Belgium)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620237
- Sponsor's protocol ID
- BA113
- Status last verified
- Oct 2026
- First submitted
- 8 Feb 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing
- ClinicalTrials.gov ID
- NCT06620237
- Acronym / sponsor ID
- BA113
- Conditions
- Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial, Cardiac Resynchronization Therapy Devices, Bradycardia, Conduction Disorder, Conduction Defect, Cardiac
- Keywords
- Conduction system pacing (CSP), Left bundle branch area pacing (LBBAP)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Implantation of the Solia CSP S pacing lead for LBBAPAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of the Solia CSP S pacing lead for LBBAPLeft bundle branch area pacing using a Solia CSP S lead | Device | LBBAP Solia CSP S |
Primary outcome
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
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
10 secondary outcomes
Amvia related SADE-d free rate
Time frame: 12 months (365 days) after implantation
Solia CSP S related SADE-d free rate
Time frame: 12 months (365 days) after implantation
Rate of successful acute CSP implantation of Solia CSP S
Time frame: At the day of implantation
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan De Pooter, MD, PhD study chair
University Hospital Ghent, Gent (Belgium)
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of the Solia CSP S pacing lead for LBBAP in people with Cardiac Pacing, Artificial and Cardiac Pacemaker, Artificial, run by Biotronik SE & Co. KG at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Belgium, France, Australia, Netherlands, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amvia related SADE-d free rate (time frame: 6 months (183 days) after implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.