Trials / Completed
CompletedNCT02059629
Eluna Family / Sentus BP Master Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 167 (actual)
- Sponsor
- Biotronik SE & Co. KG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Eluna Family / Sentus BP Master Study is designed to confirm the safety of the new Eluna pacemaker family and the Sentus BP (bipolar) left ventricular lead. Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Eluna pacemaker family | New pacemaker generation with new functions, like wandless RF telemetry "SafeSync" |
| DEVICE | Sentus BP lead | over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-02-01
- Completion
- 2016-04-01
- First posted
- 2014-02-11
- Last updated
- 2016-05-24
Locations
17 sites across 5 countries: Austria, Belgium, Denmark, Germany, Hong Kong
Source: ClinicalTrials.gov record NCT02059629. Inclusion in this directory is not an endorsement.