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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

Ventricular Arrhythmia

From 21 to 100 Years
+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactAnnette M Stine, R.N.
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 10, 2025Actual 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 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactAnnette M Stine, R.N.
Last updated: November 5, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Ventricular Arrhythmia
Criteria
2 exclusion criteria prevent from participating
Hemodynamic instability or emergency procedure
Does not consent to participate, or unable to consent to participate

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

The primary endpoint is classification accuracy of EDEN electrograms automated classifications compared with operator-determined classifications of radial depth according to a five-element ordinal scale (cameral, subendocardial, midmyocardial, subepicardial, pericardial). Agreement will be assessed using standard metrics such as concordance.

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 HospitalAtlanta, United StatesSee the location
Recruiting soonOne Study Center