The objective of this study is to confirm the safety and efficacy of the new Sentus OTW QP LV lead and Iperia ICD family. The study focuses on the safety and efficacy of the QP device system.
Study Type
OBSERVATIONAL
Enrollment
152
Landesklinikum
Sankt Pölten, Austria
Aalborg University Hospital
Aalborg, Denmark
Sentus QP LV lead: Serious Adverse Device Effect (SADE) free rate
The safety of the LV 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 LV lead will be the basis for endpoint calculation of the SADE-free rate.
Time frame: 3 months
Iperia ICD family: SADE free rate
The safety of the Iperia ICD 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.
Time frame: 3 months
LV pacing threshold
Lv pacing threshold measured in the final programmed pacing vector
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Odense University Hospital
Odense, Denmark
Aarhus University Hospital
Skejby, Denmark
Jyväskylä Central Hospital
Jyväskylä, Finland
Herz- und Diabetes Zentrum
Bad Oeynhausen, Germany
SRH Wald-Klinikum
Gera, Germany
Medizinische Hochschule Hannover
Hanover, Germany
UKSH Campus Lübeck
Lübeck, Germany
Märkische Kliniken Lüdenscheid
Lüdenscheid, Germany
...and 14 more locations