Trials / Completed
CompletedNCT03891329
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
BIO|MASTER.Cor Family Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting evidence for the clinical safety and performance of the devices.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acticor/Rivacor ICDs/CRT-Ds | pre-defined device programming, measurements and follow-up schedule |
| DEVICE | Plexa S DX | Implantation, measurements and follow-up schedule |
Timeline
- Start date
- 2019-04-30
- Primary completion
- 2020-12-21
- Completion
- 2021-09-24
- First posted
- 2019-03-27
- Last updated
- 2024-09-27
- Results posted
- 2024-09-27
Locations
13 sites across 7 countries: Austria, Germany, Hungary, Latvia, Netherlands, Slovakia, Switzerland
Source: ClinicalTrials.gov record NCT03891329. Inclusion in this directory is not an endorsement.