ALARION EV Study for Ventricular Arrhythmias
This study is testing a new device called the Parasternal Extravascular ICD System, which includes the Atala™ lead and EV-ICD Pulse Generator. This system is designed to treat serious heart rhythm problems like ventricular arrhythmia, ventricular fibrillation, and ventricular tachycardia. The study aims to see how safe and effective this system is over 6 months. You might be able to join if you are at least 18 years old and your doctor has recommended an ICD (implantable cardioverter-defibrillator) for you. The study is currently enrolling up to 280 participants worldwide.
- Study design
- This is a single-arm study, meaning all participants receive the new device. Up to 280 people will be enrolled across many sites.
- What's involved
- You will receive the Atala™ lead and EV-ICD Pulse Generator. You will have follow-up visits every 6 months after the initial 6-month period.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed every 6 months after the initial 6-month period until the study closes, which is expected to be at least 2.5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Parasternal Extravascular ICD System Pivotal Clinical Investigation (ALARION EV) Study
At a glance
Conditions
NCT07324031
Where you'd take part
This study runs at 35 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
AdventHealth
Orlando, Floridano site contact published
Not yet recruiting
Advocate/Atrium Health - Sanger Heart and Vascular
Charlotte, North Carolinano site contact published
Recruiting
Advocate/Atrium Health - Wake Forest Baptist
Winston-Salem, North Carolinano site contact published
Recruiting
Amsterdam University Medical Center
Amsterdam, AZ, Netherlandsno site contact published
Recruiting
Baptist Health
Lexington, Kentuckyno site contact published
Recruiting
Cedars-Sinai Medical Center
Santa Monica, Californiano site contact published
Not yet recruiting
Cooper Health
Voorhees Township, New Jerseyno site contact published
Not yet recruiting
East Carolina Heart Institute at ECU
Greenville, North Carolinano site contact published
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Exclusion
What this trial measures
- Freedom from MADEsThrough 6 months post-implant
Freedom from Major Adverse Device Effects (MADEs)
- Successful IVA TestAt the time of procedure and up to 60 days post-implant
Successful induced ventricular arrhythmia (IVA) test in the final system configuration