Eluna Family / Sentus BP Master Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT02059629
First received: February 7, 2014
Last updated: June 22, 2015
Last verified: June 2015
  Purpose

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 Intervention
Bradycardia
Heart Failure
Device: Eluna pacemaker family
Device: Sentus BP lead

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eluna Family / Sentus BP Master Study

Resource links provided by NLM:


Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Collection of data of interest: Handling assessment of Sentus lead during implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Collection of further data of interest: Evaluation of wandless RF telemetry function "SafeSync" in the Eluna pacemaker family [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: February 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Sentus OTW BP L

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059629

Locations
Austria
Allgemeines Krankenhaus Linz
Linz, Austria, 4020
Belgium
Cliniques du Sud Luxembourg
Arlon, Belgium, 6700
ZOL Genk
Genk, Belgium, 3600
Denmark
Aalborg Sygehus
Aalborg, Denmark, 9000
Gentofte Hospital
Hellerup, Denmark, 2900
Odense University Hospital
Odense, Denmark, 5000
Germany
Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum
Berlin, Germany, 13353
Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin
Berlin, Germany, 12203
Klinikum Lippe
Detmold, Germany, 32756
Universitätsklinikum Erlangen, Medizinische Klinik 2
Erlangen, Germany, 91054
Elisabeth Krankenhaus Essen
Essen, Germany, 45138
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
Essen, Germany, 45122
Universitäts-Herzzentrum Freiburg
Freiburg, Germany, 79106
Universitätsmedizin Greifswald
Greifswald, Germany, 17475
St. Marien-Hospital Lünen
Lünen, Germany, 44534
Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis
Saarlouis, Germany, 66740
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Principal Investigator: Georges Mairesse, Dr. med Cliniques du Sud Luxembourg
  More Information

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT02059629     History of Changes
Other Study ID Numbers: CR014
Study First Received: February 7, 2014
Last Updated: June 22, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Biotronik SE & Co. KG:
Heart failure
Eluna pacemaker family
Sentus OTW BP L left ventricular lead
Bradycardia
SADE-free rate

Additional relevant MeSH terms:
Bradycardia
Heart Failure
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 27, 2015