Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
AtaCor Medical, Inc.
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.
Description
The primary safety endpoint is Freedom from Major Adverse Device Effects (MADEs) through 6 months. The primary effectiveness endpoint is Defibrillation Performance: Successful induced ventricular arrhythmia (IVA) test in the final system configuration. Up to 40 Investigational Sites Worldwide will participate with up to 280 subjects enrolled in the study. At least 50% of subjects will be enrolled at sites in the United States. Subjects meeting indications for ICD therapy who do not require permanent bradycardia pacing will be eligible for participation. Eligible Subjects will receive an Atal…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceAtala™ lead and EV-ICD Pulse Generator
Subjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.
Locations (35)
- Honor HealthScottsdale, Arizona
- St. Bernards Heart and VascularJonesboro, Arkansas
- UC San Diego HealthLa Jolla, California
- Providence Medical FoundationOrange, California
- Cedars-Sinai Medical CenterSanta Monica, California
- MedStar Washington Hospital CenterWashington D.C., District of Columbia