Bradycardia, Heart Failure
Conditions
Keywords
Heart failure, Eluna pacemaker family, Sentus OTW BP L left ventricular lead, Bradycardia, SADE-free rate
Brief summary
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.
Interventions
DEVICEEluna pacemaker family
New pacemaker generation with new functions, like wandless RF telemetry SafeSync
DEVICESentus BP lead
over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead
Sponsors
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eluna pacemaker family: Serious Adverse Device Effect (SADE) - free rate | 6 months | 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 | 3 months | 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
| Measure | 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 |
Countries
Austria, Belgium, Denmark, Germany, Hong Kong
Outcome results
None listed