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

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

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)

Conditions4

Locations27 sites

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