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NOT YET RECRUITING
NCT07880873
PHASE1/PHASE2

Defibrio AED Study

Sponsor: Defibrio, LLC

View on ClinicalTrials.gov

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

Conditions

Interventions

DEVICE

treatment with Defibrio AED

treatment with Defibrio AED to terminate VT/VF episode