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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Tilt (65%) | Active Comparator | This is the control group, so device programming for shock energy is the default setting |
|
| Fixed Pulse Width | Active Comparator | This is the Study group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed Tilt (65%) | Device | This is the standard group, so device programming for shock energy is the default setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 5 years |
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Inclusion Criteria:
Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks
Exclusion Criteria:
• Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Fernandez, MD | Principal Investigator | |
| Javier Alzueta, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Virgen de la Victoria | Málaga | Andalusia | Spain | |||
| Hospital Puerta de Hierro |
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| Fixed Pulse Width | Device | The device has to be programmed with fixed pulse width for each phase of the biphasic waveform |
|
| Madrid |
| Spain |