CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,222 enrolled
Drug / intervention
ICD or CRT-D Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02099721
NCT02099721N/ACompleted
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Improve Sudden Cardiac Arrest Study

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Mar 31, 2014·Updated Oct 28, 2020

In Brief

A clinical study evaluating ICD or CRT-D Device for Sudden Cardiac Arrest and Ventricular Arrythmia. Completed, enrolled 4,222 participants across 93 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSudden Cardiac Arrest, Ventricular Arrythmia
CountriesArgentina, Belarus, Brazil, China, Colombia, Egypt, India, Malaysia, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan, Tunisia, United Arab Emirates
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 31, 2014
Enrollment StartMar 1, 2014
Primary CompletionJul 15, 2018
Study CompletionSep 5, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 12.3 years ago

Interventions

ICD or CRT-D Devicedevice

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.