Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Eluna Family / Sentus BP Master Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Biotronik SE & Co. KG
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT02059629
First received: February 7, 2014
Last updated: October 16, 2014
Last verified: October 2014
  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

Contacts
Contact: Evelyn Diessel, Dr. 0049 30 68905 1231 evelyn.diessel@biotronik.com

Locations
Austria
Allgemeines Krankenhaus Linz Recruiting
Linz, Austria, 4020
Contact: Clemens Steinwender, Dr.         
Principal Investigator: Clemens Steinwender, Dr.         
Belgium
Cliniques du Sud Luxembourg Recruiting
Arlon, Belgium, 6700
Contact: Georges Mairesse, Dr.         
Principal Investigator: Georges Mairesse, Dr.         
ZOL Genk Recruiting
Genk, Belgium, 3600
Contact: Wilfried Mullens, Prof. Dr.         
Principal Investigator: Wilfried Mullens, Prof. Dr.         
Denmark
Aalborg Sygehus Recruiting
Aalborg, Denmark, 9000
Contact: Ole Eschen, Dr.         
Principal Investigator: Ole Eschen, Dr.         
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Jens Haarbo, Dr.         
Principal Investigator: Jens Haarbo, Dr.         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Jens Brock Johansen, Dr.         
Principal Investigator: Jens Brock Johansen, Dr.         
Germany
Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum Recruiting
Berlin, Germany, 13353
Contact: Florian Blaschke, Dr. med.         
Principal Investigator: Florian Blaschke, PD Dr.         
Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin Not yet recruiting
Berlin, Germany, 12203
Contact: Matthias Roser, Dr.         
Principal Investigator: Matthias Roser, Dr.         
Klinikum Lippe Recruiting
Detmold, Germany, 32756
Contact: Johannes Brockmeier, Dr.med         
Principal Investigator: Johannes Brockmeier, Dr.         
Universitätsklinikum Erlangen, Medizinische Klinik 2 Recruiting
Erlangen, Germany, 91054
Contact: Martin Arnold, Dr.med.         
Principal Investigator: Martin Arnold, Dr.         
Elisabeth Krankenhaus Essen Recruiting
Essen, Germany, 45138
Contact: Dietmar Schmitz, Dr.         
Principal Investigator: Dietmar Schmitz, Dr.         
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen Not yet recruiting
Essen, Germany, 45122
Contact: Nico Reinsch, OA Dr.         
Principal Investigator: Nico Reinsch, OA Dr.         
Universitäts-Herzzentrum Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Thomas Faber, Dr.         
Principal Investigator: Thomas Faber, Dr.         
Universitätsmedizin Greifswald Recruiting
Greifswald, Germany, 17475
Contact: Mathias Busch, OA Dr.         
Principal Investigator: Mathias Busch, OA         
St. Marien-Hospital Lünen Recruiting
Lünen, Germany, 44534
Contact: Christian Perings, Prof. Dr.         
Principal Investigator: Christian Perings, Prof. Dr.         
Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis Recruiting
Saarlouis, Germany, 66740
Contact: Erik Friedrich, PD Dr.         
Principal Investigator: Erik Friedrich, PD Dr.         
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Hung Fat Tse, Prof.         
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: October 16, 2014
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 November 20, 2014