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

Study acronym: ALARION EV
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria expanded, about 22 words
    • Site details revised at 8 of 35 sites
  2. Site details revised at 7 of 35 sitesv5
  3. Site details revised at 3 of 35 sitesv4
  4. Recruitment opened
    • Trial sites expanded: 0 → 35 locations
    • Start date changed from estimate of Jul 1, 2026 to Jul 2, 2026
    v3
  5. Primary endpoint(s) modifiedv2 Show 9 more changesShow less
    • Phase changed: not specified → not applicable
    • Sponsor changed: [Redacted] to AtaCor Medical, Inc.
    • Trial status changed: Withheld → Not Yet Recruiting
    • Enrollment changed: None → 280
    • Trial arms changed: 0 → 1
    • Primary completion date: Aug 31, 2027
    • Study completion date: Dec 31, 2028
    • Start date: Jul 1, 2026
    • Study title shortened, about 3 words
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07324031
Lead Sponsor AtaCor Medical, Inc.
Conditions
(from sponsor)		 Ventricular Arrythmia, Ventricular Fibrillation, Ventricular Tachycardia
Related terms Tachycardia, Ventricular, Ventricular Fibrillation
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov