NCT07324031 Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
| NCT ID | NCT07324031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AtaCor Medical, Inc. |
| Condition | Ventricular Arrythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2026-07-02 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2026-07-02 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. The objective of the study is to demonstrate safety and effectiveness of the Parasternal EV-ICD System through 6-months.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07324031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Arrythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07324031 currently recruiting?
Yes, NCT07324031 is actively recruiting participants. Contact the research team at sarah@atacor.com for enrollment information.
Where is the NCT07324031 trial being conducted?
This trial is being conducted at Scottsdale, United States, Jonesboro, United States, La Jolla, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT07324031 clinical trial?
NCT07324031 is sponsored by AtaCor Medical, Inc.. The trial plans to enroll 280 participants.