Eluna Family / Sentus BP Master Study
|ClinicalTrials.gov Identifier: NCT02059629|
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : May 24, 2016
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.
|Condition or disease||Intervention/treatment|
|Bradycardia Heart Failure||Device: Eluna pacemaker family Device: Sentus BP lead|
|Study Type :||Observational|
|Actual Enrollment :||167 participants|
|Official Title:||Eluna Family / Sentus BP Master Study|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||April 2016|
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"
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 Name: Sentus OTW BP L
- 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.
- 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.
- Collection of data of interest: Handling assessment of Sentus lead during implantation [ Time Frame: 3 months ]
- Collection of further data of interest: Evaluation of wandless RF telemetry function "SafeSync" in the Eluna pacemaker family [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059629
|Allgemeines Krankenhaus Linz|
|Linz, Austria, 4020|
|Cliniques du Sud Luxembourg|
|Arlon, Belgium, 6700|
|Genk, Belgium, 3600|
|Aalborg, Denmark, 9000|
|Hellerup, Denmark, 2900|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin|
|Berlin, Germany, 12203|
|Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum|
|Berlin, Germany, 13353|
|Detmold, Germany, 32756|
|Universitätsklinikum Erlangen, Medizinische Klinik 2|
|Erlangen, Germany, 91054|
|Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen|
|Essen, Germany, 45122|
|Elisabeth Krankenhaus Essen|
|Essen, Germany, 45138|
|Freiburg, Germany, 79106|
|Greifswald, Germany, 17475|
|St. Marien-Hospital Lünen|
|Lünen, Germany, 44534|
|Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis|
|Saarlouis, Germany, 66740|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Georges Mairesse, Dr. med||Cliniques du Sud Luxembourg|