Improve Sudden Cardiac Arrest Study

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.

Detailed Description
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Devices allowed in the study include any Medtronic single, dual, or triple chamber defibrillator that has received appropriate license or regulatory approval and is commercially available by Medtronic in the geography in which the implant will take place. Any market-released, commercially available lead(s) can be used in the study.

Official Title
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Improve Sudden Cardiac Arrest Study

Conditions
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Sudden Cardiac Arrest, Ventricular Arrythmia

Intervention / Treatment
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* Device: ICD or CRT-D Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a Class I indication for implantation of an ICD according to the American College of Cardiology (ACC)/American Heart Association(AHA)/Heart Rhythm Society (HRS) or European Society of Cardiology (ESC) Guidelines Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form. Exclusion Criteria: Subject is ≤ 18 years of age Subject with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding) Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader Subject has any contraindication for ICD/CRT-D

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: Secondary prevention patients- device implant<br>Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects receive an ICD/CRT-D implant. | Device: ICD or CRT-D Device<br>* Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.<br>|
| No Intervention: Group B: Secondary prevention patients - no device implant<br>Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest. These subjects choose not to receive an ICD/CRT-D implant. | |
| Active Comparator: Group C: 1.5 Prevention patients - device implant<br>Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects receive an ICD/CRT-D implant. | Device: ICD or CRT-D Device<br>* Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.<br>|
| No Intervention: Group D: 1.5 prevention patients - no device implant<br>Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF). These subjects choose not to receive an ICD/CRT-D implant. | |
| Other: Group E: Primary, non-1.5 patients - device implant<br>Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects receive an ICD/CRT-D implant. | Device: ICD or CRT-D Device<br>* Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.<br>|
| No Intervention: Group F: Primary, non-1.5 patients - no device<br>Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group. These subjects choose not to receive an ICD/CRT-D implant. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the First Occurrence of a Ventricular Arrhythmia | Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C. | Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Time to all-cause mortality | Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sudden Cardiac Arrest (SCA), Syncope, Non Sustained Ventricular Tachycardia (NSVT), Premature Ventricular Contractions (PVC), Left Ventricular Ejection Fraction (LVEF), Primary Prevention, Secondary Prevention, Antitachycardia pacing (ATP), shock, appropriate therapy