NCT06018818Completed
Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Source: ClinicalTrials.gov · Last updated 24 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 129 (actual)
- First submitted
- 17 Jul 2023
- Start date
- 23 Aug 2023
- Primary completion date
- 21 Jul 2025
- Lead sponsor
- Biotronik SE & Co. KG
- Diseases
- Heart failure
- NCT number
- NCT06018818
What you commit to
- Study type: Interventional
- Participants enrolled: 129
- From 23 Aug 2023 to the primary completion date, 21 Jul 2025
- 3 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 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
- Known pregnancy or breast feeding
- Participation in another interventional clinical investigation
- Life-expectancy less than 12 months
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kepler Universitätsklinikum Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Elisabeth Krankenhaus Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Kliniken Maria Hilf GmbH Coordinator of this site? Confirm its status | Mönchengladbach | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.