Eluna Family / Sentus BP Master Study

Study Overview
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Brief Summary
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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.

Official Title
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Eluna Family / Sentus BP Master Study

Conditions
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Bradycardia, Heart Failure

Intervention / Treatment
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* Device: Eluna pacemaker family
* Device: Sentus BP lead


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: Eluna pacemaker family<br>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<br>* New pacemaker generation with new functions, like wandless RF telemetry SafeSync<br>* Other names: Epyra SR-T/DR-T/HF-T;|
| Group B: Sentus BP lead<br>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<br>* over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead<br>* Other names: Sentus OTW BP L;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Eluna pacemaker family, Sentus OTW BP L left ventricular lead, Bradycardia, SADE-free rate