Eluna Family / Sentus BP Master Study
NCT02059629 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 167
Last updated 2016-05-24
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
- Bradycardia
- Heart Failure
Interventions
- 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
Sponsors & Collaborators
-
Biotronik SE & Co. KG
lead INDUSTRY
Principal Investigators
-
Georges Mairesse, Dr. med · Cliniques du Sud Luxembourg
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2016-02-29
- Completion
- 2016-04-30
Countries
- Austria
- Belgium
- Denmark
- Germany
- Hong Kong
Study Locations
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