Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• At least 18 years old
• Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
Locations
United States
Arkansas
St. Bernards Heart and Vascular
RECRUITING
Jonesboro
Arizona
Honor Health
NOT_YET_RECRUITING
Scottsdale
California
UC San Diego Health
NOT_YET_RECRUITING
La Jolla
Providence Medical Foundation
NOT_YET_RECRUITING
Orange
Cedars-Sinai Medical Center
NOT_YET_RECRUITING
Santa Monica
Washington, D.c.
MedStar Washington Hospital Center
NOT_YET_RECRUITING
Washington D.c.
Florida
Mount Sinai Medical Center of Florida
NOT_YET_RECRUITING
Miami Beach
AdventHealth
NOT_YET_RECRUITING
Orlando
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Endeavor Health
RECRUITING
Glenview
Kentucky
Baptist Health
RECRUITING
Lexington
Maryland
John Hopkins Medical
RECRUITING
Baltimore
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Advocate/Atrium Health - Sanger Heart and Vascular
RECRUITING
Charlotte
East Carolina Heart Institute at ECU
NOT_YET_RECRUITING
Greenville
North Carolina Heart and Vascular
NOT_YET_RECRUITING
Raleigh
Advocate/Atrium Health - Wake Forest Baptist
RECRUITING
Winston-salem
Novant Health
NOT_YET_RECRUITING
Winston-salem
New Jersey
Cooper Health
NOT_YET_RECRUITING
Voorhees Township
New York
Northwell Health
RECRUITING
Manhasset
Ohio
The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
NOT_YET_RECRUITING
Cincinnati
University Hospitals of Cleveland
NOT_YET_RECRUITING
Cleveland
OhioHealth Research Institute
NOT_YET_RECRUITING
Columbus
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
NOT_YET_RECRUITING
Hershey
University of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Texas
Texas Cardiac Arrhythmia Research
RECRUITING
Austin
Other Locations
Netherlands
Amsterdam University Medical Center
RECRUITING
Amsterdam
Medical Spectrum Twente
NOT_YET_RECRUITING
Enschede
University Medical Center Groningen
NOT_YET_RECRUITING
Groningen
Maastricht University Medical Center
NOT_YET_RECRUITING
Maastricht
St. Antonius Hospital
NOT_YET_RECRUITING
Nieuwegein
Erasmus Medical Center
NOT_YET_RECRUITING
Rotterdam
Haga Hospital
NOT_YET_RECRUITING
The Hague
Isala Hospital
NOT_YET_RECRUITING
Zwolle
Contact Information
Primary
Sarah Hase, BS, CCRA
sarah@atacor.com
+1 949-545-9820
Time Frame
Start Date: 2026-07-02
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 280
Treatments
Experimental: Parasternal EV-ICD System
Subjects implanted with the Atala™ lead and EV-ICD pulse generator
Related Therapeutic Areas
Sponsors
Leads: AtaCor Medical, Inc.