RecruitingNot ApplicableNCT07324031

Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study

Sponsor

AtaCor Medical, Inc.

Enrollment

280 participants

Start Date

Jul 2, 2026

Study Type

INTERVENTIONAL

Conditions

Ventricular Tachycardia Ventricular Arrythmia Ventricular Fibrillation

Summary

The ALARION EV Study is a prospective, multi-center, single-arm, non-randomized study without concurrent or historical controls. The purpose of this pivotal study is to generate evidence of safety and effectiveness to apply for regulatory approvals for commercialization of the Parasternal EV-ICD System. The objective of the study is to demonstrate safety and effectiveness of the Parasternal EV-ICD System through 6-months.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Atala™ lead and EV-ICD Pulse Generator for people with ventricular arrythmia, ventricular fibrillation, and other related conditions. The study is currently recruiting participants at 35 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAtala™ lead and EV-ICD Pulse Generator

Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.

Locations(35)

Honor Health

Scottsdale, Arizona, United States

St. Bernards Heart and Vascular

Jonesboro, Arkansas, United States

UC San Diego Health

La Jolla, California, United States

Providence Medical Foundation

Orange, California, United States

Cedars-Sinai Medical Center

Santa Monica, California, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Mount Sinai Medical Center of Florida

Miami Beach, Florida, United States

AdventHealth

Orlando, Florida, United States

Emory University

Atlanta, Georgia, United States

Endeavor Health

Glenview, Illinois, United States

Baptist Health

Lexington, Kentucky, United States

John Hopkins Medical

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

Cooper Health

Voorhees Township, New Jersey, United States

Northwell Health

Manhasset, New York, United States

Advocate/Atrium Health - Sanger Heart and Vascular

Charlotte, North Carolina, United States

East Carolina Heart Institute at ECU

Greenville, North Carolina, United States

North Carolina Heart and Vascular

Raleigh, North Carolina, United States

Novant Health

Winston-Salem, North Carolina, United States

Advocate/Atrium Health - Wake Forest Baptist

Winston-Salem, North Carolina, United States

The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

OhioHealth Research Institute

Columbus, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Texas Cardiac Arrhythmia Research

Austin, Texas, United States

Haga Hospital

The Hague, AA, Netherlands

Isala Hospital

Zwolle, AB, Netherlands

Amsterdam University Medical Center

Amsterdam, AZ, Netherlands

St. Antonius Hospital

Nieuwegein, CM, Netherlands

Erasmus Medical Center

Rotterdam, Gelderland, Netherlands

Maastricht University Medical Center

Maastricht, HX, Netherlands

Medical Spectrum Twente

Enschede, KZ, Netherlands

University Medical Center Groningen

Groningen, RB, Netherlands

View Full Details on ClinicalTrials.gov

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NCT07324031

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