Improve Sudden Cardiac Arrest Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02099721
Study type	Interventional
Source	Medtronic Cardiac Rhythm and Heart Failure
Contact
Status	Completed
Phase	N/A
Start date	March 2014
Completion date	September 5, 2018

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