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Extravascular ICD Pivotal Study — EV ICD  

Tachycardia Clinical Trial

Official title:
Extravascular ICD Pivotal Study (EV ICD)

Clinical Trial Summary

Pivotal Summary: The study is designed to demonstrate safety and efficacy of the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System. Continued Access Summary: This study is designed to provide continued access to the Extravascular Implantable Cardioverter Defibrillator (EV ICD) System.

Clinical Trial Description

The study will enroll subjects who are indicated to receive an implantable defibrillator and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will receive an investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system, in which a lead is placed outside of the heart and veins to deliver defibrillation therapy. Subjects will be followed until regulatory approval is received. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04060680
Study type Interventional
Source Medtronic Cardiac Rhythm and Heart Failure
Contact
Status Completed
Phase N/A
Start date September 16, 2019
Completion date January 4, 2024
View Details
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