The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.
With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
735
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
North Estonia Medical Centre
Tallinn, Estonia
Tartu University Hospital
Inappropriate ICD shocks
Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation
Time frame: 12 months
ICD shocks for any reason
Freedom from automatically delivered ICD shocks for any reason during FU period
Time frame: 12 months
Inappropriate ICD therapies
Freedom from automatically delivered inappropriate ICD therapies during FU period
Time frame: 12 months
Untreated VT/VF
Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period
Time frame: 12 months
Accuracy of ICD therapy decision
Accuracy of ICD therapy decision (VT/VF and nonVT/VF)
Time frame: 12 months
Specificity
Specificity for… * … other than sustained VT/VF * … SVT (Supraventricular tachycardia) * … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT).
Time frame: 12 months
Cardiac deaths
Cardiac deaths
Time frame: 12 months
Sensitivity
Sensitivity for sustained VT/VF
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tartu, Estonia
Praxis Dr. med. Bernhardt
Annaberg-Buchholz, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Hufeland Klinikum GmbH
Bad Langensalza, Germany
Caritas Krankenhaus
Bad Mergentheim, Germany
Medizinisches Versorgungszentrum am Küchwald GmbH
Chemnitz, Germany
Praxis Dr. med. Stellmach
Chemnitz, Germany
Klinikum Coburg GmbH
Coburg, Germany
Evangelisches Krankenhaus Kalk gGmbH
Cologne, Germany
...and 13 more locations
ICD/CRT-D related SAE
ICD/CRT-D related Serious Adverse Events (SAE)
Time frame: 12 months