Cardiac Death
Conditions
Keywords
ICD, CRTD, Sudden cardiac death, Device settings, Patients who received ICD/CRTD for primary prevention of sudden cardiac death
Brief summary
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prevention ICD indication.
Detailed description
Inappropriate ICD therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk. It's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.
Interventions
DEVICEdevice settings for group A
VT zone: 350ms VF zone: 280ms
DEVICEDevice settings for group B
VT zone: 320ms VF zone: 250ms
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Approved indication for new ICD implantation for primary prevention of sudden cardiac death * Age \>=18 Years * Written informed consent
Exclusion criteria
* ICD indication for secondary prevention reasons * ICD indication for electrical disorders (i.e. long/short QT syndrome, Brugada syndrome etc...) * ICD change or upgrade * Pregnancy * Nonage * Patient is already participating to another study with active therapy arm * Patient will most likely not be able to participate to the routine follow ups in the study center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 12 months | Event free survival of: 1. inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND 2. spontaneous, documented, sustained (\>30s) ventricular tachycardia, that was not treated by the ICD |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD | 12 months |
| Number and cycle lengths of supraventricular / ventricular tachys | 12 months |
| Time to first appropriate / inappropriate ICD therapy | 12 months |
| Sensitivity for diagnosis of sustained VT | 12 months |
| Specificity for SVT diagnosis | 12 months |
| Amount of patients with appropriate / inappropriate ICD therapies | 12 months |
| Overall mortality | 12 months |
| Cardiac mortality | 12 months |
| Frequency and efficacy of ATP prior to / before capacitor charging in VF zone | 12 months |
| Amount of patients with appropriate / inappropriate shocks or ATP | 12 months |
| Quality of Life (MLHF Questionaire) | 12 months |
Countries
Germany
Outcome results
None listed