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Experimental device tested in humans – no approval yet

NCT ID NCT07324031

Knowledge-focused Sponsor: AtaCor Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 8 times

Summary

This trial is testing a medical device that has not been approved by the U.S. FDA. The purpose is to gather information about how the device works and its safety in people. Participants will be monitored closely, but the device is not yet proven to treat or cure any condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease ventricular fibrillation ventricular tachycardia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ventricular arrythmia Ventricular fibrillation Ventricular tachycardia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth

    NOT_YET_RECRUITING

    Orlando, Florida, 32803, United States

  • Advocate/Atrium Health - Sanger Heart and Vascular

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Advocate/Atrium Health - Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Amsterdam University Medical Center

    RECRUITING

    Amsterdam, AZ, 1105, Netherlands

  • Baptist Health

    RECRUITING

    Lexington, Kentucky, 40503, United States

  • Cedars-Sinai Medical Center

    NOT_YET_RECRUITING

    Santa Monica, California, 90404, United States

  • Cooper Health

    NOT_YET_RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • East Carolina Heart Institute at ECU

    NOT_YET_RECRUITING

    Greenville, North Carolina, 27834, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Endeavor Health

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Erasmus Medical Center

    NOT_YET_RECRUITING

    Rotterdam, Gelderland, 3015, Netherlands

  • Haga Hospital

    NOT_YET_RECRUITING

    The Hague, AA, 2545, Netherlands

  • Honor Health

    NOT_YET_RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Isala Hospital

    NOT_YET_RECRUITING

    Zwolle, AB, 8025, Netherlands

  • John Hopkins Medical

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Maastricht University Medical Center

    NOT_YET_RECRUITING

    Maastricht, HX, 6229, Netherlands

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • MedStar Washington Hospital Center

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Medical Spectrum Twente

    NOT_YET_RECRUITING

    Enschede, KZ, 7512, Netherlands

  • Medical University of South Carolina

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mount Sinai Medical Center of Florida

    NOT_YET_RECRUITING

    Miami Beach, Florida, 33140, United States

  • North Carolina Heart and Vascular

    NOT_YET_RECRUITING

    Raleigh, North Carolina, 27607, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • Novant Health

    NOT_YET_RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • OhioHealth Research Institute

    NOT_YET_RECRUITING

    Columbus, Ohio, 43228, United States

  • Penn State Health Milton S. Hershey Medical Center

    NOT_YET_RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Providence Medical Foundation

    NOT_YET_RECRUITING

    Orange, California, 92868, United States

  • St. Antonius Hospital

    NOT_YET_RECRUITING

    Nieuwegein, CM, 3435, Netherlands

  • St. Bernards Heart and Vascular

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Texas Cardiac Arrhythmia Research

    RECRUITING

    Austin, Texas, 78705, United States

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

    NOT_YET_RECRUITING

    Cincinnati, Ohio, 45219, United States

  • UC San Diego Health

    NOT_YET_RECRUITING

    La Jolla, California, 92037, United States

  • University Hospitals of Cleveland

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Medical Center Groningen

    NOT_YET_RECRUITING

    Groningen, RB, 9700, Netherlands

  • University of Pennsylvania

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.