Trials / Completed
CompletedNCT02774616
BIO|MASTER.Ilivia Family / Plexa
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 292 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ilivia ICD Family | pre-defined device programming, measurements and follow-up schedule |
| DEVICE | Plexa ICD lead | predefined follow-up schedule |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2017-12-01
- Completion
- 2018-03-01
- First posted
- 2016-05-17
- Last updated
- 2019-05-22
- Results posted
- 2019-03-26
Locations
25 sites across 10 countries: Australia, Austria, Denmark, France, Germany, Israel, Latvia, Singapore, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02774616. Inclusion in this directory is not an endorsement.