RecruitingVentricular ArrythmiaVentricular FibrillationVentricular Tachycardia

Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study

Eligible age

18+ yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this 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.

Sponsor: AtaCor Medical, Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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 protocol testing and data collection through the 6-month follow-up visit
✕ 7. Circumstances that may prevent data collection or completion of specified follow-up visits
✕ 8. Allergies to any device materials listed in the Instructions for Use (IFU)