This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.
The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
779
This is the standard group, so device programming for shock energy is the default setting
The device has to be programmed with fixed pulse width for each phase of the biphasic waveform
Hospital Virgen de la Victoria
Málaga, Andalusia, Spain
Hospital Puerta de Hierro
Madrid, Spain
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm
Rate of rhythm conversion from Ventricular Tachyarrhythmia to sinus rhythm by the first appropriate shock programmed to 25 Joules (or equivalent voltage) programming the shock waveform in Fixed Pulse Width (Study Group) versus the Fixed Tilt with value 65% (Control Group).
Time frame: 5 years
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