Extravascular ICD Pivotal Study

Completed · Not applicable

Conditions studied: Tachycardia, Ventricular Arrythmia

In brief

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.

Key facts

Study ID

NCT04060680

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

393

Starts

2019-09-16

Expected to finish

2024-01-04

Last updated by the study team

2024-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of California San Diego (UCSD) — La Jolla, California, United States
• Continued Access: Sequoia Hospital — Redwood City, California, United States
• Sequoia Hospital — Redwood City, California, United States
• Continued Access: Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• MedStar Wahsington Hospital Center — Washington D.C., District of Columbia, United States
• Baptist Health — Jacksonville, Florida, United States
• Continued Access: Baptist Health — Jacksonville, Florida, United States
• AdventHealth Cardiovascular Research Institute — Orlando, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• Iowa Heart Center — Des Moines, Iowa, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Continued Access: University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States
• University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Continued Access: Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States
• Saint Luke's Mid America Heart Institute — Kansas City, Missouri, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Continued Access: Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Continued Access: North Shore University Hospital — Manhasset, New York, United States
• North Shore Uniersity Hospital — Manhasset, New York, United States
• New York-Presbyterian Hospital/Weill Cornell Medical Center — New York, New York, United States
• HonorHealth Cardiac Arrhythmia Group - Osborn — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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