The extravascular implantable cardioverter-defibrillator: The pivotal study plan.

ABSTRACT:

Background

Transvenous implantable cardioverter defibrillators (TV ICD) provide life-saving therapy for millions of patients worldwide. However, they are susceptible to several potential short- and long- term complications including cardiac perforation and pneumothorax, lead dislodgement, venous obstruction, and infection. The extravascular ICD system's novel design and substernal implant approach avoids the risks associated with TV ICDs while still providing pacing features and similar generator size to TV ICDs.

Study design

The EV ICD pivotal study is a prospective, multicenter, single-arm, nonrandomized, premarket clinical study designed to examine the safety and acute efficacy of the system. This study will enroll up to 400 patients with a Class I or IIa indication for i

SUBMITTER: Crozier I 

PROVIDER: S-EPMC9290824 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature