Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAtaCor Medical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old
Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines or ESC guidelines
Disqualifiers
Patients who cannot read or write
Expected survival < 1 year
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
Participation in any concurrent clinical study without prior approval from the Sponsor
Trial design
Design model
Single group
Treatments tested in this trial
Atala™ lead and EV-ICD Pulse Generator
DeviceSubjects will receive the Atala™ lead and EV-ICD pulse generator being evaluated in the study.
Treatment groups
280 Participants
are divided into 1 treatment groupGroup A: Parasternal EV-ICD SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from MADEs
Freedom from Major Adverse Device Effects (MADEs)
Time frame
Through 6 months post-implant2
Successful IVA Test
Successful induced ventricular arrhythmia (IVA) test in the final system configuration
Time frame
At the time of procedure and up to 60 days post-implantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov