NCT07324031 · AtaCor Medical, Inc.
Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
(ALARION EV)
What this study is about
The ALARION EV Study is a forward-looking, multi-center, single-treatment group$1, non-randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
Atala™ lead and EV-ICD Pulse Generator
Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.
Primary outcome measures
Freedom from MADEs
Time frame: Through 6 months post-implant
Freedom from Major Adverse Device Effects (MADEs)
Successful IVA Test
Time frame: At the time of procedure and up to 60 days post-implant
Successful induced ventricular arrhythmia (IVA) test in the final system configuration
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- Currently on inotropic therapy
- Known history of pericardial disease, pericarditis or mediastinitis
- Risk factors associated with defibrillation testing:
- Severe aortic stenosis
- Current Intracardiac LA or LV thrombus
- Severe proximal three-vessel or left main coronary artery disease without revascularization
- Hemodynamic instability
- Unstable angina
- Recent stroke or transient ischemic attack (within the last 3 months)
- Known inadequate external defibrillation
- LVEF \< 20% (most recent assessment; must be within 180 days of consent)
- LVEDD \>70 mm (most recent assessment; must be within 180 days of consent)
Where
- Scottsdale, Arizona
- Jonesboro, Arkansas
- La Jolla, California
- Orange, California
- Santa Monica, California
- Washington D.C., District of Columbia
- Miami Beach, Florida
- Orlando, Florida
- Atlanta, Georgia
- Glenview, Illinois
- Lexington, Kentucky
- Baltimore, Maryland
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations