Sudden Cardiac Death
Conditions
Keywords
Risk stratification method, negative predictive value, fast ventricular arrhythmias, ICD, The negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
Brief summary
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
Interventions
DEVICEOvatio VR 6250 or DR6550
The study requires the implantation of locally approved material: * A right ventricular defibrillation lead * In case of use of a dual chamber ICD a right atrial pacing lead * A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study. Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar.
Sponsors
LivaNova
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines * CHF since \> 3 months and * LVEF \< 35% and * NYHA class II or III OR * Prior Myocardial infarction since more than 4 weeks and * LVEF \< 30%
Exclusion criteria
* Documented spontaneous sustained ventricular tachycardia * Prior implant of any device for ventricular cardiac pacing * Existing indication for permanent ventricular pacing * Myocardial infarction within 4 weeks prior to enrollment * Arrhythmogenic RV-Dysplasia * Brugada syndrome * Long QT syndrome * Performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical) * Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system. * Excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient * Permanent chronic atrial fibrillation / flutter * Patient is unable to attend the scheduled follow-up visits at the participating centre * Patient is already included in another ongoing clinical study * Patient is unable to understand the objectives of the study * Patient refuses to cooperate * Patient is unable or refuses to provide informed consent * Patient is minor (less than 18-year old) * Patient has life expectancy of less than 1 year * Patient is pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TAV score and number of tachyarrhythmic events. | The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases. |
Secondary
| Measure | Time frame |
|---|---|
| TAV change | 12 months of follow up |
Countries
Canada, Germany, Spain, United States
Outcome results
None listed