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

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

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.

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)