Tachycardia
Conditions
Keywords
ICD, CRT-D, Sudden cardiac death, Device settings, Optimized programming strategy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEICD with enhanced SVT discriminators
ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic or nonischemic cardiomyopathy * Primary prevention or secondary prevention of Sudden cardiac death (SCD) * Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber) * The patient is ≥ 18 years of age * The patient is able to understand the patient information and is capable to provide informed consent. * The patient has provided written informed consent prior to any investigational related procedure
Exclusion criteria
* Previously implanted ICD/CRT-D * Hypertrophic (with or without obstructive) cardiomyopathy * Ion channel disorders (Long/Short-QT, Brugada syndrome etc…) * New York Heart Association (NYHA) Class IV * Recent cardiac decompensation (within previous 3 months) * The patient is unable to comply with the follow up schedule. * The patient is participating in another investigational device or drug investigation. * The patient is pregnant or is planning to become pregnant during the duration of the investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inappropriate ICD shocks | 12 months | Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inappropriate ICD therapies | 12 months | Freedom from automatically delivered inappropriate ICD therapies during FU period |
| Untreated VT/VF | 12 months | Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period |
| Accuracy of ICD therapy decision | 12 months | Accuracy of ICD therapy decision (VT/VF and nonVT/VF) |
| ICD shocks for any reason | 12 months | Freedom from automatically delivered ICD shocks for any reason during FU period |
| Cardiac deaths | 12 months | Cardiac deaths |
| Sensitivity | 12 months | Sensitivity for sustained VT/VF |
| ICD/CRT-D related SAE | 12 months | ICD/CRT-D related Serious Adverse Events (SAE) |
| Specificity | 12 months | Specificity for… * … other than sustained VT/VF * … SVT (Supraventricular tachycardia) * … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT). |
Countries
Estonia, Germany
Outcome results
None listed