NCT05610176Completed
BIO|CONCEPT.Amvia Study
BIO|CONCEPT.Amvia, First in Human Study for the Amvia/Solvia Pacemaker Family
Source: ClinicalTrials.gov · Last updated 24 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 2 Nov 2022
- Start date
- 23 Nov 2022
- Primary completion date
- 11 Jun 2024
- Lead sponsor
- Biotronik Australia Pty Ltd.
- Diseases
- Heart failure
- NCT number
- NCT05610176
What you commit to
- Study type: Interventional
- Participants enrolled: 52
- From 23 Nov 2022 to the primary completion date, 11 Jun 2024
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Age less than 18 years
Other
- Planned for conduction system pacing
- Pregnant or breast feeding
- Participation in another interventional clinical investigation according to the definition given in the study protocol
- Life-expectancy less than 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advara Heart Care Wesley Coordinator of this site? Confirm its status | Auchenflower | Australia | Unknown status |
| Peninsula Heart Centre Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Unknown status |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| John Hunter Hospital Coordinator of this site? Confirm its status | New Lambton Heights | Australia | Unknown status |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.