Improve Sudden Cardiac Arrest Study

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Time to the First Occurrence of a Ventricular Arrhythmia	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).	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.

Secondary Outcome Measures

Name	Time	Method
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).	Time to all-cause mortality

Locations (88): Hospital Churruca
🇦🇷
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷
Buenos Aires, Argentina
Hospital Universitario Fundación Favaloro
🇦🇷
Buenos Aires, Argentina
Instituto Cardiovascular de Buenos Aires (ICBA)
🇦🇷
Buenos Aires, Argentina
Republican Scientific and Practical Center "Cardiology"
🇧🇾
Minsk, Belarus
Real e Benemérita Associação Portuguesa de Beneficência
🇧🇷
São Paulo, Sao Paulo, Brazil
INCOR - Hospital das Clínicas da Faculdade de Medicina da USP
🇧🇷
São Paulo, Brazil
Anhui Provincial Hospital
🇨🇳
Hefei, Anhui, China
Xiamen Heart Center
🇨🇳
Xiamen, Fujian, China
Wuhan Asia Heart Hospital
🇨🇳
Wuhan, Hubei, China
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Hospital Churruca
🇦🇷Buenos Aires, Argentina