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.
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
- Conditions the study is for
- Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
- 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.
35 sites in 2 countries
United States27 sites, 27 recruiting
- 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
- Not yet recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Anne Kroman, DO
Anne Kroman, DO
- 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
- Not yet 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
- Recruiting
Endeavor Health
Glenview, Illinois, 60026
Mark Metzl, MD
Mark Metzl, MD
- Not yet 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
- Recruiting
St. Bernards Heart and Vascular
Jonesboro, Arkansas, 72401
Devi Nair, MD
Devi Nair, MD
- Not yet recruiting
UC San Diego Health
La Jolla, California, 92037
Ulrika Birgersdotter-Green, MD
Ulrika Birgersdotter-Green, MD
- 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
- Not yet 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
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Paul Friedman, MD
Paul Friedman, MD
- Not yet 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
- Recruiting
Advocate/Atrium Health - Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Satish Misra, MD
Satish Misra, MD
Netherlands8 sites, 8 recruiting
- 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
- Not yet 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
- 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
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 group | Role | What they receive |
|---|---|---|
| Parasternal EV-ICD System | Experimental | Subjects 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.
Freedom from MADEs
Freedom from Major Adverse Device Effects (MADEs)
Measured: Through 6 months post-implant
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.
- First posted7 Jan 2026
- Study start2 Jul 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AtaCor Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
- ClinicalTrials.gov ID
- NCT07324031
- Acronym / sponsor ID
- ALARION EV / DOC-10325
- Keywords
- Ventricular Defibrillation, Extravascular
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- AtaCor Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parasternal EV-ICD System | Experimental | Device: Atala™ lead and EV-ICD Pulse GeneratorSubjects implanted with the Atala™ lead and EV-ICD pulse generator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atala™ lead and EV-ICD Pulse GeneratorSubjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study. | Device | Parasternal EV-ICD System |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Related trials for Ventricular Arrythmia
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EDEN Intracardiac Electrogram Recording and Classifying System
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Assessment of Combined CCM and ICD Device in HFrEF
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Physical Impairments in Premature Ventricular Complex
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A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 2 countries: see every site and its status.
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.