The study enrolled subjects who are indicated to receive an implantable defibrillator and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects received 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.
Clinicaltrials.gov ID: NCT04060680
Link to clinicaltrials.gov for study description
Other resources:
Press release: Medtronic Extravascular ICD global clinical trial results reinforce device safety and effectiveness