Improve Sudden Cardiac Arrest Study
Improve Sudden Cardiac Arrest Study
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.
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.
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