BradycardiaNCT05610176
BIO|CONCEPT.Amvia Study
A study testing Amvia Sky pacemaker or CRT-P device in people with Bradycardia and Heart Failure, run by Biotronik Australia Pty Ltd. at 7 sites in 2 countries.
Trial summary
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Heart Failure
- What is being tested?
- Amvia Sky pacemaker or CRT-P device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 23 Nov 2022to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations
- 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 for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)
- Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- Pregnant or breast feeding
- Age less than 18 years
- Participation in another interventional clinical investigation according to the definition given in the study protocol
- Life-expectancy less than 12 months
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
Advara Heart Care Wesley
Auchenflower, Queensland, 4066
Peninsula Heart Centre
Frankston, Victoria, 3199
Royal Hobart Hospital
Hobart, Tasmania, 7001
The Alfred Hospital
Melbourne, Victoria, 3004
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Gold Coast University Hospital
Southport, Queensland, 4215
About this study
Official title: BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.
- Conditions
- Bradycardia, Heart Failure
- Being tested
- Amvia Sky pacemaker or CRT-P device
- Keywords
- Cardiac pacemaker, CRT-P
- 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 Sky pacemaker or CRT-P deviceDevice
Subjects with an indication for a pacemaker or CRT-P device will be implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. Device programming will be done according to the medical needs of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Amvia Sky pacemaker or CRT-P implantation | Experimental | Patients implanted with an Amvia Sky pacemaker or CRT-P device Receives: Device: Amvia Sky pacemaker or CRT-P device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months
Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate
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 posted9 Nov 2022
- Study start23 Nov 2022
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik Australia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Justin Mariani, Dr, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610176
- Sponsor's protocol ID
- BA115
- Status last verified
- Jun 2024
- First submitted
- 2 Nov 2022
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
- ClinicalTrials.gov ID
- NCT05610176
- Acronym / sponsor ID
- BA115
- Conditions
- Bradycardia, Heart Failure
- Keywords
- Cardiac pacemaker, CRT-P
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Biotronik Australia Pty Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Posted 24 Jul 2025
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 exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amvia Sky pacemaker or CRT-P implantation | Experimental | Device: Amvia Sky pacemaker or CRT-P devicePatients implanted with an Amvia Sky pacemaker or CRT-P device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations
- 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 (7 listed)
- Planned for conduction system pacing
- Planned for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)
- Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
- Pregnant or breast feeding
- Age less than 18 years
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 Sky pacemaker or CRT-P deviceSubjects with an indication for a pacemaker or CRT-P device will be implanted with an Amvia Sky device of the Amvia/Solvia pacemaker family according to standard pacemaker implantation procedures. Device programming will be done according to the medical needs of the subjects. | Device | Amvia Sky pacemaker or CRT-P implantation |
Primary outcome
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months
Time frame: 12 months
Descriptive statistics of the investigational device related SADE-free rate after first implantation attempt will be calculated using a Kaplan-Meier estimate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Justin Mariani, Dr principal investigator
The Alfred
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amvia Sky pacemaker or CRT-P device in people with Bradycardia and Heart Failure, run by Biotronik Australia Pty Ltd. at 7 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 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: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, 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?
Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serious Adverse Device Effect (SADE)-Free Rate After 12 Months (time frame: 12 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 Jul 2025.