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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eluna pacemaker family | Device | New pacemaker generation with new functions, like wandless RF telemetry "SafeSync" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate | 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 | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Collection of data of interest: Handling assessment of Sentus lead during implantation | 3 months | |
| Collection of further data of interest: Evaluation of wandless RF telemetry function "SafeSync" in the Eluna pacemaker family | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from available pacemaker or CRT patients directly by the treating physician at the investigational site
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| Name | Affiliation | Role |
|---|---|---|
| Georges Mairesse, Dr. med | Cliniques du Sud Luxembourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allgemeines Krankenhaus Linz | Linz | 4020 | Austria | |||
| Cliniques du Sud Luxembourg |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Sentus BP lead | Device | over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead |
|
|
| Arlon |
| 6700 |
| Belgium |
| ZOL Genk | Genk | 3600 | Belgium |
| Aalborg Sygehus | Aalborg | 9000 | Denmark |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Charité Universitätsmedizin Berlin, CBF: Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Charité - Universitätsmedizin Berlin, CVK: Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Klinikum Lippe | Detmold | 32756 | Germany |
| Universitätsklinikum Erlangen, Medizinische Klinik 2 | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen, Westdeutsches Herzzentrum Essen | Essen | 45122 | Germany |
| Elisabeth Krankenhaus Essen | Essen | 45138 | Germany |
| Universitäts-Herzzentrum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsmedizin Greifswald | Greifswald | 17475 | Germany |
| St. Marien-Hospital Lünen | Lünen | 44534 | Germany |
| Marienhaus GmbH St. Elisabeth Krankenhaus Saarlouis | Saarlouis | 66740 | Germany |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| D013568 |
| Pathological Conditions, Signs and Symptoms |