Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population

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.

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

• Subjects who are willing to be registered on the Merlin.net remote follow-up program
• Subject ≥18 years
• Subjects with life expectancy of at least 1 year
• Subjects who agree to comply with the follow-up program included in this protocol

Exclusion criteria

• • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months

• Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment
• Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment
• Functional NYHA Class IV
• Subjects who are participating in another ICD or CRT-D study
• Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives
• Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)