Status: Recruiting
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.
Participants needed: 280
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: AtaCor Medical, Inc.Updated: Aug 6, 2026Locations: 35
Eligibility criteria
At least 18 years old [+1]
Patients who cannot read or write [+32]