Eluna Family / Sentus BP Master Study

May 23, 2016 updated by: Biotronik SE & Co. KG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Allgemeines Krankenhaus Linz
  • Belgium
      • Arlon, Belgium, 6700
        • Cliniques du Sud Luxembourg
      • Genk, Belgium, 3600
        • ZOL GENK
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Sygehus
      • Hellerup, Denmark, 2900
        • Gentofte Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
  • Germany
      • Berlin, Germany, 12203
        • Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum
      • Detmold, Germany, 32756
        • Klinikum Lippe
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen, Medizinische Klinik 2
      • Essen, Germany, 45138
        • Elisabeth Krankenhaus Essen
      • Essen, Germany, 45122
        • Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
      • Freiburg, Germany, 79106
        • Universitäts-Herzzentrum Freiburg
      • Greifswald, Germany, 17475
        • Universitätsmedizin Greifswald
      • Lünen, Germany, 44534
        • St. Marien-Hospital Lünen
      • Saarlouis, Germany, 66740
        • Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from available pacemaker or CRT patients directly by the treating physician at the investigational site

Description

Inclusion Criteria:

  • Patient is willing to participate in the study and provided written informed consent
  • Patient meets standard indication for pacemaker or CRT-P or CRT-D therapy
  • Patient accepts Home Monitoring® concept
  • Patient has legal capacity and ability to consent

Exclusion Criteria:

  • Patient with any contraindication to pacemaker and CRT-P and CRT-D therapy
  • Patient under the age of 18
  • Pregnant or breast-feeding women
  • Cardiac surgery planned within the next 6 months
  • Life expectancy less than 12 months
  • Participation in another cardiac clinical investigation with active treatment arm
  • Group B only: Currently implanted with an endocardial or epicardial LV lead or had prior attempt to place a LV lead (for CRT implants only)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A: Eluna pacemaker family
Patients with standard indication for pacemaker therapy or Cardiac Resynchronization Therapy (CRT), who will be implanted with a pacemaker or CRT device of the Eluna pacemaker family. Single-, Dual- and Tripple-chamber pacemakers are applicable.
Device: Eluna pacemaker family
New pacemaker generation with new functions, like wandless RF telemetry "SafeSync"
Other Names:
  • Eluna SR-T/DR-T/HF-T
  • Etrinsa SR-T/DR-T/HF-T
  • Epyra SR-T/DR-T/HF-T
Group B: Sentus BP lead
Heart failure patients with indication for Cardiac Resynchronization Therapy (CRT) therapy, who will be implanted with the left ventricular Sentus BP lead. Patients can receive either CRT pacemaker or CRT-D (CRT with defibrillator function).
Device: Sentus BP lead
over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead
Other Names:
  • Sentus OTW BP L

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate
Time Frame: 6 months
The safety of the Eluna pacemaker family will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the pacemaker will be the basis for endpoint calculation of the SADE-free rate.
6 months
Sentus BP lead: Serious Adverse Device Effect (SADE) - free rate
Time Frame: 3 months
The safety of the Sentus BP left ventricular lead will be evaluated by asking the investigator to record any adverse event. While all adverse events have to be recorded throughout the study, only the number of SADEs possibly or securely related to the Sentus BP lead will be the basis for endpoint calculation of the SADE free rate.
3 months

Other Outcome Measures

Outcome Measure
Time Frame
Collection of data of interest: Handling assessment of Sentus lead during implantation
Time Frame: 3 months
3 months
Collection of further data of interest: Evaluation of wandless RF telemetry function "SafeSync" in the Eluna pacemaker family
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Georges Mairesse, Dr. med, Cliniques du Sud Luxembourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 7, 2014

First Posted (ESTIMATE)

February 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2016

Last Update Submitted That Met QC Criteria

May 23, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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