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
Qualifiers
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
Treatments tested in this trial
- Atala™ lead and EV-ICD Pulse Generator
Treatment groups
280 Participants
are divided into 1 treatment groupLocations
35Netherlands
Haga Hospital2545, The HagueAA, Netherlands
Isala Hospital8025, ZwolleAB, Netherlands
Amsterdam University Medical Center1105, AmsterdamAZ, Netherlands
St. Antonius Hospital3435, NieuwegeinCM, Netherlands
Sponsors and collaborators
AtaCor Medical, Inc.
Lead sponsor
Source ClinicalTrials.gov