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

Recruiting now · Not applicable

Conditions studied: Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia

In brief

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.

Key facts

Study ID

NCT07324031

Run by

AtaCor Medical, Inc.

People needed

280

Starts

2026-07-02

Expected to finish

2028-12-31

Last updated by the study team

2026-08-06

Who can join

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

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:
• Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure
• Known obstructed or restricted pathway into the mediastinum for the Atala™ lead
• Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type
• Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
• History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure
• Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax
• Surgically corrected congenital heart disease (not including catheter-based procedures)
• Cardiac Related:
• Indication for permanent bradycardia pacing or cardiac resynchronization therapy
• Decompensated heart failure

Where it is running

• Advocate/Atrium Health - Sanger Heart and Vascular — Charlotte, North Carolina, United States (enrolling)
• St. Bernards Heart and Vascular — Jonesboro, Arkansas, United States (enrolling)
• Amsterdam University Medical Center — Amsterdam, AZ, Netherlands (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• 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
• 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
• 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

Full record on ClinicalTrials.gov

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