Trials / Completed
CompletedNCT06018818
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 129 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Amvia/Solvia pacemaker family | Implantation of a pacemaker or CRT-P devices |
Timeline
- Start date
- 2023-08-23
- Primary completion
- 2025-07-21
- Completion
- 2025-07-21
- First posted
- 2023-08-31
- Last updated
- 2025-08-24
Locations
3 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT06018818. Inclusion in this directory is not an endorsement.