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Defibrio AED Study
Sponsor: Defibrio, LLC
Summary
The purpose of this research is to test an investigational device called the Defibrio AED (automated external defibrillator). The researchers are conducting the study to determine if the Defibrio AED is safe to use and is able to restore normal heart rhythm after an episode of VF (ventricular fibrillation) or VT (ventricular tachycardia). The study will enroll 25 subjects in the United States. Participants that experience VF, or polymorphic VT, or pulseless VT, during an electrophysiology study or procedure will be treated with the Defibrio AED to restore normal heart rhythm. Electrocardiography data will be collected from the clinical records, along with medical history, laboratory results, and medications information.
Official title: A Multi-Center, Prospective, Safety And Performance Evaluation Study On The Automated External Defibrillation Of Patients With VF/VT Using The Defibrio AED
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-11
Completion Date
2027-10
Last Updated
2026-10-19
Healthy Volunteers
No
Interventions
treatment with Defibrio AED
treatment with Defibrio AED to terminate VT/VF episode