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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ventricular Arrythmia

Intervention / Treatment
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* Device: Fixed Tilt (65%)
* Device: Fixed Pulse Width


Participation Criteria
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Eligibility Criteria
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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 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed Tilt (65%)<br>This is the control group, so device programming for shock energy is the default setting | Device: Fixed Tilt (65%)<br>* This is the standard group, so device programming for shock energy is the default setting<br>|
| Active Comparator: Fixed Pulse Width<br>This is the Study group. | Device: Fixed Pulse Width<br>* The device has to be programmed with fixed pulse width for each phase of the biphasic waveform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |