Intracardiac Electrogram Recording and Classification System
EDEN Intracardiac Electrogram Recording and Classifying System
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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