The ALARION EV Study is testing a new medical device called the Parasternal EV-ICD System. This system is designed to help people who have a risk of dangerous heart rhythms but do not need a pacemaker. The device will be placed near the heart and is connected with a special lead to help detect and correct these heart rhythms. The study will check if the device is safe and effective over six months. Participants will need to visit the study site every six months for follow-ups, and the study might last at least 2.5 years. Around 280 people will participate, with 50% from the United States. To join, you must be at least 18, meet certain heart health guidelines, and not have other health conditions that could interfere with the study.
- Study lasts at least 2.5 years.
- Participants visit every 6 months.
- Device aims to safely manage heart rhythms.
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