Clinical Trial

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

Study acronym: ALARION EV
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 8 changes
critical Recruitment opened 2026-07-14
notable Trial sites expanded: 0 -> 35 locations 2026-07-14
critical Trial status changed: Withheld → Not Yet Recruiting 2026-07-01
critical Phase changed: not specified -> not applicable 2026-07-01
critical Primary endpoint(s) modified 2026-07-01
notable Enrollment changed: None -> 280 2026-07-01
notable Sponsor changed: [Redacted] -> AtaCor Medical, Inc. 2026-07-01
minor Trial arms changed: 0 -> 1 2026-07-01
Trial Details
NCT Number NCT07324031
Lead Sponsor AtaCor Medical, Inc.
Conditions Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
Enrollment 280 participants
Start Date 2026-07-02
Primary Completion 2027-08-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-06