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

September 2, 2026 updated by: AtaCor Medical, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary safety endpoint is Freedom from Major Adverse Device Effects (MADEs) through 6 months. The primary effectiveness endpoint is Defibrillation Performance: Successful induced ventricular arrhythmia (IVA) test in the final system configuration.

Up to 40 Investigational Sites Worldwide will participate with up to 280 subjects enrolled in the study. At least 50% of subjects will be enrolled at sites in the United States.

Subjects meeting indications for ICD therapy who do not require permanent bradycardia pacing will be eligible for participation. Eligible Subjects will receive an Atala™ lead connected to an EV-ICD Pulse Generator positioned in a left pectoral or left lateral location. The Parasternal EV-ICD System will be tested to verify appropriate sensing and defibrillation.

Starting at 6 months, Subjects will be followed every 6 months until the study is closed. The study is expected to be ongoing for a minimum of 2.5 years from the date of first enrollment. Endpoints will be analyzed and summarized in a final study report after all active Subjects have completed the 6-month visit.

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sarah Hase, BS, CCRA
  • Phone Number: +1 949-545-9820
  • Email: sarah@atacor.com

Study Locations

  • Netherlands
    • AA
      • The Hague, AA, Netherlands, 2545
        • Not yet recruiting
        • Haga Hospital
        • Contact:
          • Shmaila Saleem-Talib, MD
        • Principal Investigator:
          • Shmaila Saleem-Talib, MD
    • AB
      • Zwolle, AB, Netherlands, 8025
        • Not yet recruiting
        • Isala Hospital
        • Contact:
          • Sébastien Krul, MD
        • Principal Investigator:
          • Sébastien Krul, MD
    • AZ
      • Amsterdam, AZ, Netherlands, 1105
        • Recruiting
        • Amsterdam University Medical Center
        • Contact:
          • Louise Olde Nordkamp, MD
        • Principal Investigator:
          • Louise Olde Nordkamp, MD
    • CM
      • Nieuwegein, CM, Netherlands, 3435
        • Not yet recruiting
        • St. Antonius Hospital
        • Contact:
          • Vincent Van Dijk, MD
        • Principal Investigator:
          • Vincent Van Dijk, MD
    • Gelderland
      • Rotterdam, Gelderland, Netherlands, 3015
        • Not yet recruiting
        • Erasmus Medical Center
        • Contact:
          • Sing Yap, MD
        • Principal Investigator:
          • Sing Yap, MD
    • HX
      • Maastricht, HX, Netherlands, 6229
        • Not yet recruiting
        • Maastricht University Medical Center
        • Contact:
          • Twan van Stipdonk, MD
        • Principal Investigator:
          • Twan van Stipdonk, MD
    • KZ
      • Enschede, KZ, Netherlands, 7512
        • Not yet recruiting
        • Medical Spectrum Twente
        • Contact:
          • Jurren van Opstal, MD
        • Principal Investigator:
          • Jurren van Opstal, MD
    • RB
      • Groningen, RB, Netherlands, 9700
        • Not yet recruiting
        • University Medical Center Groningen
        • Contact:
          • Michiel Rienstra, MD
        • Principal Investigator:
          • Michiel Rienstra, MD
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Not yet recruiting
        • Honor Health
        • Contact:
          • Rahul Doshi, MD
        • Principal Investigator:
          • Rahul Doshi, MD
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • St. Bernards Heart and Vascular
        • Principal Investigator:
          • Devi Nair, MD
        • Contact:
          • Devi Nair, MD
    • California
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UC San Diego Health
        • Contact:
          • Ulrika Birgersdotter-Green, MD
        • Principal Investigator:
          • Ulrika Birgersdotter-Green, MD
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Providence Medical Foundation
        • Contact:
          • Thuy Le, MD
        • Principal Investigator:
          • Thuy Le, MD
      • Santa Monica, California, United States, 90404
        • Not yet recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Shephal Doshi, MD
        • Contact:
          • Shephal Doshi, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Not yet recruiting
        • MedStar Washington Hospital Center
        • Contact:
          • Cyrus Hadadi, MD
        • Principal Investigator:
          • Cyrus Hadadi, MD
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Not yet recruiting
        • Mount Sinai Medical Center of Florida
        • Contact:
          • Raul Weiss, MD
        • Principal Investigator:
          • Raul Weiss, MD
      • Orlando, Florida, United States, 32803
        • Not yet recruiting
        • AdventHealth
        • Principal Investigator:
          • Naushad Shaik, MD
        • Contact:
          • Naushad Shaik, MD
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Contact:
          • Mikhael El Chami, MD
        • Principal Investigator:
          • Mikhael El Chami, MD
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Endeavor Health
        • Principal Investigator:
          • Mark Metzl, MD
        • Contact:
          • Mark Metzl, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health
        • Principal Investigator:
          • Johan Aasbo, DO
        • Contact:
          • Johan Aasbo, DO
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • John Hopkins Medical
        • Principal Investigator:
          • Edward Powers, MD
        • Contact:
          • Edward Powers, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Paul Friedman, MD
        • Contact:
          • Paul Friedman, MD
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • Not yet recruiting
        • Cooper Health
        • Principal Investigator:
          • Andrea Russo, MD
        • Contact:
          • Andrea Russo, MD
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Laurence Epstein, MD
        • Contact:
          • Laurence Epstein, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Advocate/Atrium Health - Sanger Heart and Vascular
        • Principal Investigator:
          • Satish Misra, MD
        • Contact:
          • Satish Misra, MD
      • Greenville, North Carolina, United States, 27834
        • Not yet recruiting
        • East Carolina Heart Institute at ECU
        • Contact:
          • Rajesekhar Nekkanti, MD
        • Principal Investigator:
          • Rajesekhar Nekkanti, MD
      • Raleigh, North Carolina, United States, 27607
        • Not yet recruiting
        • North Carolina Heart and Vascular
        • Contact:
          • Sidharth Shah, MD
        • Principal Investigator:
          • Sidharth Shah, MD
      • Winston-Salem, North Carolina, United States, 27103
        • Not yet recruiting
        • Novant Health
        • Principal Investigator:
          • Michael Drucker, MD
        • Contact:
          • Michael Drucker, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Advocate/Atrium Health - Wake Forest Baptist
        • Principal Investigator:
          • Satish Misra, MD
        • Contact:
          • Satish Misra, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Not yet recruiting
        • The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
        • Principal Investigator:
          • Daniel Pelchovitz, MD
        • Contact:
          • Daniel Pelchovitz, MD
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Hospitals of Cleveland
        • Contact:
          • Judith Mackall, MD
        • Principal Investigator:
          • Judith Mackall, MD
      • Columbus, Ohio, United States, 43228
        • Not yet recruiting
        • OhioHealth Research Institute
        • Contact:
          • Anish Amin, MD
        • Principal Investigator:
          • Anish Amin, MD
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Not yet recruiting
        • Penn State Health Milton S. Hershey Medical Center
        • Principal Investigator:
          • Soraya Samii, MD
        • Contact:
          • Soraya Samii, MD
      • Philadelphia, Pennsylvania, United States, 19104
        • Not yet recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Robert Schaller, MD
        • Contact:
          • Robert Schaller, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
        • Contact:
          • Anne Kroman, DO
        • Principal Investigator:
          • Anne Kroman, DO
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Research
        • Principal Investigator:
          • Amin Al-Ahmad, MD
        • Contact:
          • Amin Al-Ahmad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. At least 18 years old
  2. Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines

Exclusion Criteria:

  1. Patients who cannot read or write
  2. Expected survival < 1 year
  3. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
  4. Participation in any concurrent clinical study without prior approval from the Sponsor
  5. Inability or unwillingness to provide informed consent to participate in the study
  6. Any known circumstances which may prevent the completion of protocol testing and data collection through the 6-month follow-up visit
  7. Circumstances that may prevent data collection or completion of specified follow-up visits
  8. Allergies to any device materials listed in the Instructions for Use (IFU)
  9. Contraindication for temporary suspension of oral/systemic anticoagulation

  10. Known history of lung disease with FEV1 < 1.0 Liter

    Device Related:

  11. 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
  12. Implanted with a subcutaneous ICD lead, subcutaneous coils/arrays, epicardial patches or epicardial pace/sense leads

  13. Any known need for MRI prior to approval of MRI conditional labeling

    Anatomy Related:

  14. Known structural abnormalities of the heart that may increase risk of the Parasternal EV-ICD System procedure
  15. Known obstructed or restricted pathway into the mediastinum for the Atala™ lead
  16. Prior surgery with disruption of the lung, pericardium or connective tissue between the sternum and pericardium, including sternotomy of any type
  17. Known significant anatomic derangement of or within the thorax (e.g., pectus excavatum, significant scoliosis)
  18. History of thoracic radiation therapy or other medical treatments/conditions which may complicate the Parasternal EV-ICD System implant procedure
  19. Known adhesions in the thorax or history of medical treatments, surgeries or conditions that increase the potential for adhesions in the thorax

  20. Surgically corrected congenital heart disease (not including catheter-based procedures)

    Cardiac Related:

  21. Indication for permanent bradycardia pacing or cardiac resynchronization therapy
  22. Decompensated heart failure
  23. Currently on inotropic therapy
  24. Known history of pericardial disease, pericarditis or mediastinitis

  25. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parasternal EV-ICD System
Subjects implanted with the Atala™ lead and EV-ICD pulse generator
Device: Atala™ lead and EV-ICD Pulse Generator
Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from MADEs
Time Frame: Through 6 months post-implant
Freedom from Major Adverse Device Effects (MADEs)
Through 6 months post-implant
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
At the time of procedure and up to 60 days post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtaCor Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC-10325

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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