Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
ALARION EV
1 other identifier
interventional
280
2 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Typical duration for not_applicable
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedStudy Start
First participant enrolled
July 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 13, 2026
July 1, 2026
1.2 years
January 5, 2026
July 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom from MADEs
Freedom from Major Adverse Device Effects (MADEs)
Through 6 months post-implant
Successful IVA Test
Successful induced ventricular arrhythmia (IVA) test in the final system configuration
At the time of procedure and up to 60 days post-implant
Study Arms (1)
Parasternal EV-ICD System
EXPERIMENTALSubjects implanted with the Atala™ lead and EV-ICD pulse generator
Interventions
Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who cannot read or write
- Expected survival \< 1 year
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Participation in any concurrent clinical study without prior approval from the Sponsor
- Inability or unwillingness to provide informed consent to participate in the study
- Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
- Circumstances that may prevent data collection or completion of specified follow-up visits
- Allergies to any device materials listed in the Instructions for Use (IFU)
- Contraindication for temporary suspension of oral/systemic anticoagulation
- Known history of lung disease with FEV1 \< 1.0 Liter
- Device Related:
- Implanted with or planned implantation of any device which delivers current in the body that may interfere with therapy delivery, including, but not limited to a pacemaker, LVAD or neurostimulator
- Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads
- Any known need for MRI prior to approval of MRI conditional labeling
- Anatomy Related:
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Honor Health
Scottsdale, Arizona, 85258, United States
St. Bernards Heart and Vascular
Jonesboro, Arkansas, 72401, United States
UC San Diego Health
La Jolla, California, 92037, United States
Providence Medical Foundation
Orange, California, 92868, United States
Cedars-Sinai Medical Center
Santa Monica, California, 90404, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Mount Sinai Medical Center of Florida
Miami Beach, Florida, 33140, United States
AdventHealth
Orlando, Florida, 32803, United States
Emory University
Atlanta, Georgia, 30308, United States
Endeavor Health
Glenview, Illinois, 60026, United States
Baptist Health
Lexington, Kentucky, 40503, United States
John Hopkins Medical
Baltimore, Maryland, 21287, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Cooper Health
Voorhees Township, New Jersey, 08043, United States
Northwell Health
Manhasset, New York, 11030, United States
Advocate/Atrium Health - Sanger Heart and Vascular
Charlotte, North Carolina, 28204, United States
East Carolina Heart Institute at ECU
Greenville, North Carolina, 27834, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, 27607, United States
Novant Health
Winston-Salem, North Carolina, 27103, United States
Advocate/Atrium Health - Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
OhioHealth Research Institute
Columbus, Ohio, 43228, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705, United States
Haga Hospital
The Hague, AA, 2545, Netherlands
Isala Hospital
Zwolle, AB, 8025, Netherlands
Amsterdam University Medical Center
Amsterdam, AZ, 1105, Netherlands
St. Antonius Hospital
Nieuwegein, CM, 3435, Netherlands
Erasmus Medical Center
Rotterdam, Gelderland, 3015, Netherlands
Maastricht University Medical Center
Maastricht, HX, 6229, Netherlands
Medical Spectrum Twente
Enschede, KZ, 7512, Netherlands
University Medical Center Groningen
Groningen, RB, 9700, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2026
First Posted
January 7, 2026
Study Start
July 2, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
July 13, 2026
Record last verified: 2026-07