NCT04060680

Extravascular ICD Pivotal Study

Extravascular ICD Pivotal Study (EV ICD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 393 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tachycardia
• Ventricular Arrythmia

Interventions

Type	Name	Description
DEVICE	Defibrillation using the Extravascular ICD	VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.

Timeline

• Start date: 2019-09-16
• Primary completion: 2022-04-28
• Completion: 2024-01-04
• First posted: 2019-08-19
• Last updated: 2024-11-19
• Results posted: 2023-07-03

Locations

56 sites across 17 countries: United States, Australia, Austria, Canada, Denmark, France, Hong Kong, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study