Eluna Family / Sentus BP Master Study

NCT02059629 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 167

Last updated 2016-05-24

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02059629 on ClinicalTrials.gov