Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
292
pre-defined device programming, measurements and follow-up schedule
predefined follow-up schedule
Liverpool Hospital
Liverpool, Australia
Ilivia Family Related SADE-free Rate Through 3 Months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device
Time frame: 3 months
Plexa Related SADE-free Rate Through 6 Months
This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the "Plexa" lead
Time frame: 6 months
Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up
Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by "ATP-one-shot", the percentage of patients with at least one successful termination will be determined
Time frame: 6 months
Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up
The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate
Time frame: 3 months
Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up
The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Nambour General Hospital
Nambour, Australia
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Odense University Hospital
Odense, Denmark
CHU Brest
Brest, France
Hufeland Klinikum GmbH
Bad Langensalza, Germany
HDZ NRW Bad Oeynhausen
Bad Oeynhausen, Germany
Städtisches Klinikum Brandenburg GmbH
Brandenburg, Germany
Universitätsklinikum Erlangen
Erlangen, Germany
Universitätsklinikum Essen
Essen, Germany
...and 15 more locations