What this study is
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.
What's being tested
- Atala™ lead and EV-ICD Pulse Generator
Intervention · DEVICE
Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.
Study details
- Sponsor
- AtaCor Medical, Inc.
- Conditions
- Ventricular Arrythmia · Ventricular Fibrillation · Ventricular Tachycardia
- Enrolling
- 280 people
- Starts
- 2026-07-02
- Est. completion
- 2028-12-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (35)
35 openHonor Health
Scottsdale, Arizona, United States
- Rahul Doshi, MD · Contact
- Rahul Doshi, MD · Principal investigator
Not yet recruitingSt. Bernards Heart and Vascular
Jonesboro, Arkansas, United States
- Devi Nair, MD · Contact
- Devi Nair, MD · Principal investigator
RecruitingUC San Diego Health
La Jolla, California, United States
- Ulrika Birgersdotter-Green, MD · Contact
- Ulrika Birgersdotter-Green, MD · Principal investigator
Not yet recruitingProvidence Medical Foundation
Orange, California, United States
- Thuy Le, MD · Contact
- Thuy Le, MD · Principal investigator
Not yet recruitingCedars-Sinai Medical Center
Santa Monica, California, United States
- Shephal Doshi, MD · Contact
- Shephal Doshi, MD · Principal investigator
Not yet recruitingMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
- Cyrus Hadadi, MD · Contact
- Cyrus Hadadi, MD · Principal investigator
Not yet recruitingMount Sinai Medical Center of Florida
Miami Beach, Florida, United States
- Raul Weiss, MD · Contact
- Raul Weiss, MD · Principal investigator
RecruitingAdventHealth
Orlando, Florida, United States
- Naushad Shaik, MD · Contact
- Naushad Shaik, MD · Principal investigator
Not yet recruitingEmory University
Atlanta, Georgia, United States
- Mikhael El Chami, MD · Contact
- Mikhael El Chami, MD · Principal investigator
RecruitingEndeavor Health
Glenview, Illinois, United States
- Mark Metzl, MD · Contact
- Mark Metzl, MD · Principal investigator
RecruitingBaptist Health
Lexington, Kentucky, United States
- Johan Aasbo, DO · Contact
- Johan Aasbo, DO · Principal investigator
RecruitingJohn Hopkins Medical
Baltimore, Maryland, United States
- Edward Powers, MD · Contact
- Edward Powers, MD · Principal investigator
RecruitingMayo Clinic
Rochester, Minnesota, United States
- Paul Friedman, MD · Contact
- Paul Friedman, MD · Principal investigator
RecruitingCooper Health
Voorhees Township, New Jersey, United States
- Andrea Russo, MD · Contact
- Andrea Russo, MD · Principal investigator
Not yet recruitingNorthwell Health
Manhasset, New York, United States
- Laurence Epstein, MD · Contact
- Laurence Epstein, MD · Principal investigator
RecruitingAdvocate/Atrium Health - Sanger Heart and Vascular
Charlotte, North Carolina, United States
- Satish Misra, MD · Contact
- Satish Misra, MD · Principal investigator
RecruitingEast Carolina Heart Institute at ECU
Greenville, North Carolina, United States
- Rajesekhar Nekkanti, MD · Contact
- Rajesekhar Nekkanti, MD · Principal investigator
Not yet recruitingNorth Carolina Heart and Vascular
Raleigh, North Carolina, United States
- Sidharth Shah, MD · Contact
- Sidharth Shah, MD · Principal investigator
Not yet recruitingNovant Health
Winston-Salem, North Carolina, United States
- Michael Drucker, MD · Contact
- Michael Drucker, MD · Principal investigator
Not yet recruitingAdvocate/Atrium Health - Wake Forest Baptist
Winston-Salem, North Carolina, United States
- Satish Misra, MD · Contact
- Satish Misra, MD · Principal investigator
RecruitingThe Carl & Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, United States
- Daniel Pelchovitz, MD · Contact
- Daniel Pelchovitz, MD · Principal investigator
RecruitingUniversity Hospitals of Cleveland
Cleveland, Ohio, United States
- Judith Mackall, MD · Contact
- Judith Mackall, MD · Principal investigator
Not yet recruitingOhioHealth Research Institute
Columbus, Ohio, United States
- Anish Amin, MD · Contact
- Anish Amin, MD · Principal investigator
Not yet recruitingPenn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
- Soraya Samii, MD · Contact
- Soraya Samii, MD · Principal investigator
Not yet recruitingUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
- Robert Schaller, MD · Contact
- Robert Schaller, MD · Principal investigator
Not yet recruitingMedical University of South Carolina
Charleston, South Carolina, United States
- Anne Kroman, DO · Contact
- Anne Kroman, DO · Principal investigator
Not yet recruitingTexas Cardiac Arrhythmia Research
Austin, Texas, United States
- Amin Al-Ahmad, MD · Contact
- Amin Al-Ahmad, MD · Principal investigator
Recruiting
8 sites outside the US
Haga Hospital
The Hague, AA, Netherlands
- Shmaila Saleem-Talib, MD · Contact
- Shmaila Saleem-Talib, MD · Principal investigator
RecruitingIsala Hospital
Zwolle, AB, Netherlands
- Sébastien Krul, MD · Contact
- Sébastien Krul, MD · Principal investigator
RecruitingAmsterdam University Medical Center
Amsterdam, AZ, Netherlands
- Louise Olde Nordkamp, MD · Contact
- Louise Olde Nordkamp, MD · Principal investigator
RecruitingSt. Antonius Hospital
Nieuwegein, CM, Netherlands
- Vincent Van Dijk, MD · Contact
- Vincent Van Dijk, MD · Principal investigator
Not yet recruitingErasmus Medical Center
Rotterdam, Gelderland, Netherlands
- Sing Yap, MD · Contact
- Sing Yap, MD · Principal investigator
RecruitingMaastricht University Medical Center
Maastricht, HX, Netherlands
- Twan van Stipdonk, MD · Contact
- Twan van Stipdonk, MD · Principal investigator
Not yet recruitingMedical Spectrum Twente
Enschede, KZ, Netherlands
- Jurren van Opstal, MD · Contact
- Jurren van Opstal, MD · Principal investigator
RecruitingUniversity Medical Center Groningen
Groningen, RB, Netherlands
- Michiel Rienstra, MD · Contact
- Michiel Rienstra, MD · Principal investigator
Not yet recruiting
Study team
Sponsor
AtaCor Medical, Inc.
Study ID DOC-10325
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.