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Ventricular ArrythmiaALARION EVNCT07324031

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

A study testing Atala™ lead and EV-ICD Pulse Generator in people with Ventricular Arrythmia and Ventricular Fibrillation, run by AtaCor Medical, Inc. at 35 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atala™ lead and EV-ICD Pulse Generator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
35 sitesin 2 countries
Study dates
2 Jul 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 37Show fewer
  • 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)

Trial locations and contacts

35 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Sarah Hase, BS, CCRA contact

+1 949-545-9820

sarah@atacor.com

35 sites in 2 countries

United States27 sites, 27 recruiting
  • Emory University

    Atlanta, Georgia, 30308

    Mikhael El Chami, MD

    Mikhael El Chami, MD

    Recruiting
  • Texas Cardiac Arrhythmia Research

    Austin, Texas, 78705

    Amin Al-Ahmad, MD

    Amin Al-Ahmad, MD

    Recruiting
  • John Hopkins Medical

    Baltimore, Maryland, 21287

    Edward Powers, MD

    Edward Powers, MD

    Recruiting
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Anne Kroman, DO

    Anne Kroman, DO

    Not yet recruiting
  • Advocate/Atrium Health - Sanger Heart and Vascular

    Charlotte, North Carolina, 28204

    Satish Misra, MD

    Satish Misra, MD

    Recruiting
  • The Carl & Edyth Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio, 45219

    Daniel Pelchovitz, MD

    Daniel Pelchovitz, MD

    Recruiting
  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

    Judith Mackall, MD

    Judith Mackall, MD

    Not yet recruiting
  • OhioHealth Research Institute

    Columbus, Ohio, 43228

    Anish Amin, MD

    Anish Amin, MD

    Not yet recruiting
  • Endeavor Health

    Glenview, Illinois, 60026

    Mark Metzl, MD

    Mark Metzl, MD

    Recruiting
  • East Carolina Heart Institute at ECU

    Greenville, North Carolina, 27834

    Rajesekhar Nekkanti, MD

    Rajesekhar Nekkanti, MD

    Not yet recruiting
  • Penn State Health Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Soraya Samii, MD

    Soraya Samii, MD

    Not yet recruiting
  • St. Bernards Heart and Vascular

    Jonesboro, Arkansas, 72401

    Devi Nair, MD

    Devi Nair, MD

    Recruiting
  • UC San Diego Health

    La Jolla, California, 92037

    Ulrika Birgersdotter-Green, MD

    Ulrika Birgersdotter-Green, MD

    Not yet recruiting
  • Baptist Health

    Lexington, Kentucky, 40503

    Johan Aasbo, DO

    Johan Aasbo, DO

    Recruiting
  • Northwell Health

    Manhasset, New York, 11030

    Laurence Epstein, MD

    Laurence Epstein, MD

    Recruiting
  • Mount Sinai Medical Center of Florida

    Miami Beach, Florida, 33140

    Raul Weiss, MD

    Raul Weiss, MD

    Recruiting
  • Providence Medical Foundation

    Orange, California, 92868

    Thuy Le, MD

    Thuy Le, MD

    Not yet recruiting
  • AdventHealth

    Orlando, Florida, 32803

    Naushad Shaik, MD

    Naushad Shaik, MD

    Not yet recruiting
  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Robert Schaller, MD

    Robert Schaller, MD

    Not yet recruiting
  • North Carolina Heart and Vascular

    Raleigh, North Carolina, 27607

    Sidharth Shah, MD

    Sidharth Shah, MD

    Not yet recruiting
  • Mayo Clinic

    Rochester, Minnesota, 55902

    Paul Friedman, MD

    Paul Friedman, MD

    Recruiting
  • Cedars-Sinai Medical Center

    Santa Monica, California, 90404

    Shephal Doshi, MD

    Shephal Doshi, MD

    Not yet recruiting
  • Honor Health

    Scottsdale, Arizona, 85258

    Rahul Doshi, MD

    Rahul Doshi, MD

    Not yet recruiting
  • Cooper Health

    Voorhees Township, New Jersey, 08043

    Andrea Russo, MD

    Andrea Russo, MD

    Not yet recruiting
  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Cyrus Hadadi, MD

    Cyrus Hadadi, MD

    Not yet recruiting
  • Novant Health

    Winston-Salem, North Carolina, 27103

    Michael Drucker, MD

    Michael Drucker, MD

    Not yet recruiting
  • Advocate/Atrium Health - Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

    Satish Misra, MD

    Satish Misra, MD

    Recruiting

Other trials in United States

Netherlands8 sites, 8 recruiting
  • Amsterdam University Medical Center

    Amsterdam, AZ, 1105

    Louise Olde Nordkamp, MD

    Louise Olde Nordkamp, MD

    Recruiting
  • Medical Spectrum Twente

    Enschede, KZ, 7512

    Jurren van Opstal, MD

    Jurren van Opstal, MD

    Recruiting
  • University Medical Center Groningen

    Groningen, RB, 9700

    Michiel Rienstra, MD

    Michiel Rienstra, MD

    Not yet recruiting
  • Maastricht University Medical Center

    Maastricht, HX, 6229

    Twan van Stipdonk, MD

    Twan van Stipdonk, MD

    Not yet recruiting
  • St. Antonius Hospital

    Nieuwegein, CM, 3435

    Vincent Van Dijk, MD

    Vincent Van Dijk, MD

    Not yet recruiting
  • Erasmus Medical Center

    Rotterdam, Gelderland, 3015

    Sing Yap, MD

    Sing Yap, MD

    Recruiting
  • Haga Hospital

    The Hague, AA, 2545

    Shmaila Saleem-Talib, MD

    Shmaila Saleem-Talib, MD

    Recruiting
  • Isala Hospital

    Zwolle, AB, 8025

    Sébastien Krul, MD

    Sébastien Krul, MD

    Recruiting

Other trials in Netherlands

About this study

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.

Read the 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.

Being tested
Atala™ lead and EV-ICD Pulse Generator
Keywords
Ventricular Defibrillation, Extravascular
Medical subject headings
Ventricular Fibrillation, Tachycardia, Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atala™ lead and EV-ICD Pulse GeneratorDevice

    Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.

Study groups in NCT07324031
Study groupRoleWhat they receive
Parasternal EV-ICD SystemExperimentalSubjects implanted with the Atala™ lead and EV-ICD pulse generator
Receives: Device: Atala™ lead and EV-ICD Pulse Generator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from MADEs

    Freedom from Major Adverse Device Effects (MADEs)

    Measured: Through 6 months post-implant

  2. Successful IVA Test

    Successful induced ventricular arrhythmia (IVA) test in the final system configuration

    Measured: At the time of procedure and up to 60 days post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start2 Jul 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324031
Sponsor's protocol ID
DOC-10325
Acronym
ALARION EV
Status last verified
Oct 2026
First submitted
5 Jan 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Atala™ lead and EV-ICD Pulse Generator in people with Ventricular Arrythmia and Ventricular Fibrillation, run by AtaCor Medical, Inc. at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah Hase, BS, CCRA (+1 949-545-9820, sarah@atacor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from MADEs (time frame: Through 6 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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