Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
167 participants
OBSERVATIONAL
2014-02-28
2016-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Furthermore the new wandless RF telemetry function "SafeSync" and the handling of the Sentus lead during implantation will be assessed.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BIO|MASTER.Edora Family Study
NCT03091322
BioMonitor Master Study
NCT01725568
Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
NCT00916344
BIO.MASTER.BioMonitor 2 Study
NCT02565238
MODULA Modul 5 BEAT-HF
NCT00273091
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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).
Sentus BP lead
over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eluna pacemaker family
New pacemaker generation with new functions, like wandless RF telemetry "SafeSync"
Sentus BP lead
over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik SE & Co. KG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Georges Mairesse, Dr. med
Role: PRINCIPAL_INVESTIGATOR
Cliniques du Sud Luxembourg
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Allgemeines Krankenhaus Linz
Linz, , Austria
Cliniques du Sud Luxembourg
Arlon, , Belgium
ZOL Genk
Genk, , Belgium
Aalborg Sygehus
Aalborg, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Odense University Hospital
Odense, , Denmark
Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin
Berlin, , Germany
Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum
Berlin, , Germany
Klinikum Lippe
Detmold, , Germany
Universitätsklinikum Erlangen, Medizinische Klinik 2
Erlangen, , Germany
Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen
Essen, , Germany
Elisabeth Krankenhaus Essen
Essen, , Germany
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
St. Marien-Hospital Lünen
Lünen, , Germany
Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis
Saarlouis, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.