NCT02099721

Improve Sudden Cardiac Arrest Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,222 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sudden Cardiac Arrest
• Ventricular Arrythmia

Interventions

Type	Name	Description
DEVICE	ICD or CRT-D Device	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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-07-15
• Completion: 2018-09-05
• First posted: 2014-03-31
• Last updated: 2020-10-28
• Results posted: 2020-10-28

Locations

93 sites across 16 countries: Argentina, Belarus, Brazil, China, Colombia, Egypt, India, Malaysia, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan, Tunisia, United Arab Emirates