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Intracardiac Electrogram Recording and Classification System

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What is being tested

EDEN Intracardiac Electrogram Recording and Classifying System

Device
Who is being recruted

From 21 to 100 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactAnnette M Stine, R.N.More contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 29, 2026

Actual date on which the first participant was enrolled.

This study explores a special medical device that records and analyzes electrical signals from the heart. The focus is on the EDEN system, which helps classify these signals, known as intracardiac electrograms. The study does not make any diagnostic or treatment decisions based on the findings. It aims to see if the system accurately identifies certain categories related to heart signal patterns. This work is vital because better classification of heart signals can improve understanding of heart functions and aid future developments in heart care. Participants in the study will undergo procedures where intracardiac electrograms are recorded. The main task is to assess how accurately the system classifies these signals. Researchers also look at how these recordings relate to other heart imaging results, like CT and MRI scans, focusing on aspects like heart muscle thickness or scarring. The study evaluates if changes in heart signal patterns, either natural or caused during procedures, affect the system's readings. There are no direct risks or benefits to participants, as the study's purpose is purely observational and technical.

Official TitleEDEN Intracardiac Electrogram Recording and Classifying System 
NCT07137455
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactAnnette M Stine, R.N.More contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 exclusion criteria prevent from participating
Does not consent to participate, or unable to consent to participate

Hemodynamic instability or emergency procedure

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Emory University Hospital

Atlanta, United StatesSee the location
Recruiting soonOne Study Center