BradycardiaNCT06018818
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
A study testing Amvia/Solvia pacemaker family in people with Bradycardia and Heart Failure, run by Biotronik SE & Co. KG at 3 sites in 2 countries.
Trial summary
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Bradycardia, Heart Failure
- What is being tested?
- Amvia/Solvia pacemaker family
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Aug 2023to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
- Ability to understand the nature of the study
- Willingness to provide written informed consent
- 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
- Planned for conduction system pacing
- Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- Known pregnancy or breast feeding
- Age less than 18 years
- Participation in another interventional clinical investigation
- Life-expectancy less than 12 months
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Elisabeth-Krankenhaus Essen
Essen
Kliniken Maria Hilf GmbH
Mönchengladbach
About this study
Official title: BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.
- Conditions
- Bradycardia, Heart Failure
- Being tested
- Amvia/Solvia pacemaker family
- Medical subject headings
- Bradycardia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amvia/Solvia pacemaker familyDevice
Implantation of a pacemaker or CRT-P devices
| Study group | Role | What they receive |
|---|---|---|
| Amvia pacemaker or CRT-P implantation | Other | Not described Receives: Device: Amvia/Solvia pacemaker family |
What is being measured
The primary outcome is the main question the study is designed to answer.
SADE-free rate at 6 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
Measured: 6 months
Secondary outcomes (9)
SADE-free rate at 12 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 12 months
Measured: 12 months
CRT AutoAdapt performance
CRT AutoAdapt: different pacing percentages
Measured: 12 months
CRT AutoAdapt AV delay
Mean adapted AV delay after pace/sense
Measured: 12 months
Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
Measured: 12 months
Auto LV VectorOpt
Time needed for threshold measurement
Measured: 12 months
Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Investigator appraisal of the overall handling of the feature (score: very good/good/ adequate/poor/very poor)
Measured: 2 months
aATP-related ADEs and SADEs
aATP-related ADEs and SADEs
Measured: 12 months
Sensing performance of device-based measurements
The appropriateness of sensing performance will be assessed by calculating the percentage of appropriate sensing for all leads.
Measured: 12 months
Pacing performance of device-based measurements
The appropriateness of pacing performance will be assessed by calculating the percentage of appropriate pacing for all leads.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start23 Aug 2023
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Istvan Szendey, Dr., Principal investigator, Kliniken Maria Hilf GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018818
- Sponsor's protocol ID
- BA114
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
- ClinicalTrials.gov ID
- NCT06018818
- Acronym / sponsor ID
- BA114
- Conditions
- Bradycardia, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 31 Aug 2023 (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 study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amvia pacemaker or CRT-P implantation | Other | Device: Amvia/Solvia pacemaker family |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
- Ability to understand the nature of the study
- Willingness to provide written informed consent
- 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
Key exclusion criteria (6 listed)
- Planned for conduction system pacing
- Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- Known pregnancy or breast feeding
- Age less than 18 years
- Participation in another interventional clinical investigation
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 |
|---|---|---|
| Amvia/Solvia pacemaker familyImplantation of a pacemaker or CRT-P devices | Device | Amvia pacemaker or CRT-P implantation |
Primary outcome
SADE-free rate at 6 months
Time frame: 6 months
Kaplan-Meier estimate of Amvia-related SADE-free rate at 6 months
9 secondary outcomes
SADE-free rate at 12 months
Time frame: 12 months
CRT AutoAdapt performance
Time frame: 12 months
CRT AutoAdapt AV delay
Time frame: 12 months
Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
Time frame: 12 months
Auto LV VectorOpt
Time frame: 12 months
Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
Time frame: 2 months
aATP-related ADEs and SADEs
Time frame: 12 months
Sensing performance of device-based measurements
Time frame: 12 months
Pacing performance of device-based measurements
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Istvan Szendey, Dr. principal investigator
Kliniken Maria Hilf GmbH
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amvia/Solvia pacemaker family in people with Bradycardia and Heart Failure, run by Biotronik SE & Co. KG at 3 sites in 2 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SADE-free rate at 6 months (time frame: 6 months). 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 24 Aug 2025.