EDEN Intracardiac Electrogram Recording and Classifying System
Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Aug 21, 2025
Trial Information
Current as of November 07, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new heart monitoring system called the EDEN system. During certain heart procedures, doctors use special machines to record the heart’s electrical signals directly from the heart to help guide treatment. The EDEN system is designed to work alongside these machines to record and analyze the heart’s signals in a new way. The goal is to see how well the EDEN system works without affecting the patient’s care.
People who are 21 years or older and need to have specific heart procedures for irregular heartbeats (called ventricular arrhythmia) or for pacing the heart’s electrical system may be eligible to join. If you take part, you will have your planned heart procedure as usual. The EDEN system will be connected to the equipment already used during your procedure, and a small sticker-like electrode might be placed on your body to help with the recordings. No extra tests or follow-up visits are needed, and the EDEN system’s information will not be used to make medical decisions during your care.
Gender
ALL
Eligibility criteria
- • INCLUSION CRITERIA
- • Age \>= 21 years
- • Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure
- • EXCLUSION CRITERIA
- • Does not consent to participate, or unable to consent to participate
- • Hemodynamic instability or emergency procedure
About National Heart, Lung, And Blood Institute (Nhlbi)
The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Patients applied
Trial Officials
Robert J Lederman, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported