Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
NCT07324031 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2026-08-06
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.
Conditions
- Ventricular Arrythmia
- Ventricular Fibrillation
- Ventricular Tachycardia
Interventions
- DEVICE
-
Atala™ lead and EV-ICD Pulse Generator
Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.
Sponsors & Collaborators
-
AtaCor Medical, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-02
- Primary Completion
- 2027-08-31
- Completion
- 2028-12-31
- FDA Device
- Yes
Countries
- United States
- Netherlands
Study Locations
More Related Trials
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02312141 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03123341 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03748316 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07223801 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07215793 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02430441 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01773941 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02284321 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06042101 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07120412 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03124732 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03642431 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00790621 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03235791 ·Status: WITHHELD
-
EASEE® System Pivotal Study for the United States of America
NCT07301346 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT06793423 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT01820741 ·Status: WITHHELD
-
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
NCT07298317 ·Status: RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT03147482 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00208481 ·Status: WITHHELD
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT00824018 ·Status: WITHHELD
-
Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for OUD
NCT07348796 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT02231034 ·Status: WITHHELD
-
A Randomized, Active-Controlled, Double-Masked, Crossover Study to Evaluate the Clinical Performance of Deseyne (Vifilcon C) Daily Disposable Soft Contact Lens for Presbyopia Extended Depth of Focus (EDOF)
NCT06698731 ·Status: COMPLETED ·Phase: NA
-
[Trial of device that is not approved or cleared by the U.S. FDA]
NCT07296432 ·Status: WITHHELD