Ventricular ArrhythmiaNCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
A study testing EDEN Intracardiac Electrogram Recording and Classifying System in people with Ventricular Arrhythmia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Heart surgeons use electrocardiogram (ECG) machines to record electrical signals from the heart during procedures. Normal ECG machines connect only to the skin. Special ECG machines connect directly to the heart; they are a safer option during procedures. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Ventricular Arrhythmia
- What is being tested?
- EDEN Intracardiac Electrogram Recording and Classifying System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 21 years
- Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure
Who cannot join
- Does not consent to participate, or unable to consent to participate
- Hemodynamic instability or emergency procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Background:
Heart surgeons use electrocardiogram (ECG) machines to record electrical signals from the heart during procedures. Normal ECG machines connect only to the skin. Special ECG machines connect directly to the heart; they are a safer option during procedures. Researchers want to test a new ECG machine called the EDEN system.
Read more
Objective:
To test the EDEN system in people having heart procedures. The new system will be used along with an approved special ECG machine.
Eligibility:
People aged 21 years or older who need to have a heart procedure. These procedures can include (1) electrophysiology mapping or ablation; and (2) conduction system pacing.
Design:
Researchers will review participants' medical records. No extra tests are needed.
Participants will have their heart procedure as planned.
The EDEN system will be linked to the special ECG used during the procedure. An extra electrode may be placed on the participant's body. Electrodes are small stickers attached to wires that go to the machine.
The EDEN system will record and analyze electrical signals already being measured. It will not interfere with participants' care. No medical decisions well be made based on its data.
No follow-up visits are needed for this study....
Read the detailed description
Study Description:
The study tests a hardware electrocardiography appliance used to record and classify intracardiac electrograms obtained in the practice of medicine. No diagnoses or clinical decisions are based on the findings in this study.
Objectives:
The primary objective is to determine whether the classifier accurately identifies the EDEN radial depth category.
Endpoints:
Primary endpoint: The primary endpoint is classifier accuracy.
Exploratory endpoints: Correspondence of EDEN electrograms with CT and CMR findings (of myocardial segmental thickness, scar, and possibly relaxometry); Impact of abnormal conduction, induced or observed during the EP procedure, on EDEN electrogram morphology. Technical success of acquiring and classifying EDEN electrograms.
- Conditions
- Ventricular Arrhythmia
- Being tested
- EDEN Intracardiac Electrogram Recording and Classifying System
- Keywords
- intracardiac electrogram, radial depth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDEN Intracardiac Electrogram Recording and Classifying SystemDevice
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.
| Study group | Role | What they receive |
|---|---|---|
| EDEN Intracardiac Electrogram Recording and Classifying System | Experimental | EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine. Receives: Device: EDEN Intracardiac Electrogram Recording and Classifying System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classifier accuracy
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.
Measured: During intracardiac electrograms procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start29 Oct 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert J Lederman, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137455
- Sponsor's protocol ID
- 10002526
- Other IDs
- 002526-H
- Status last verified
- 2 Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underline results in a publication will be shared. Medical images will not be shared because of intrinsic inability to protect confidentiality with reasonable effort.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EDEN Intracardiac Electrogram Recording and Classifying System
- ClinicalTrials.gov ID
- NCT07137455
- Acronym / sponsor ID
- 10002526
- Conditions
- Ventricular Arrhythmia
- Keywords
- intracardiac electrogram, radial depth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Heart surgeons use electrocardiogram (ECG) machines to record electrical signals from the heart during procedures. Normal ECG machines connect only to the skin. Special ECG machines connect directly to the heart; they are a safer option during procedures. Researchers want to test a new ECG machine called the EDEN system.
Objective:
To test the EDEN system in people having heart procedures. The new system will be used along with an approved special ECG machine.
Eligibility:
People aged 21 years or older who need to have a heart procedure. These procedures can include (1) electrophysiology mapping or ablation; and (2) conduction system pacing.
Design:
Researchers will review participants' medical records. No extra tests are needed.
Participants will have their heart procedure as planned.
The EDEN system will be linked to the special ECG used during the procedure. An extra electrode may be placed on the participant's body. Electrodes are small stickers attached to wires that go to the machine.
The EDEN system will record and analyze electrical signals already being measured. It will not interfere with participants' care. No medical decisions well be made based on its data.
No follow-up visits are needed for this study....
Detailed description
Study Description:
The study tests a hardware electrocardiography appliance used to record and classify intracardiac electrograms obtained in the practice of medicine. No diagnoses or clinical decisions are based on the findings in this study.
Objectives:
The primary objective is to determine whether the classifier accurately identifies the EDEN radial depth category.
Endpoints:
Primary endpoint: The primary endpoint is classifier accuracy.
Exploratory endpoints: Correspondence of EDEN electrograms with CT and CMR findings (of myocardial segmental thickness, scar, and possibly relaxometry); Impact of abnormal conduction, induced or observed during the EP procedure, on EDEN electrogram morphology. Technical success of acquiring and classifying EDEN electrograms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EDEN Intracardiac Electrogram Recording and Classifying System | Experimental | Device: EDEN Intracardiac Electrogram Recording and Classifying SystemEDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >= 21 years
- Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure
Key exclusion criteria (2 listed)
- Does not consent to participate, or unable to consent to participate
- Hemodynamic instability or emergency procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDEN Intracardiac Electrogram Recording and Classifying SystemEDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine. | Device | EDEN Intracardiac Electrogram Recording and Classifying System |
Primary outcome
Classifier accuracy
Time frame: During intracardiac electrograms procedure
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD that underline results in a publication will be shared. Medical images will not be shared because of intrinsic inability to protect confidentiality with reasonable effort.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert J Lederman, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDEN Intracardiac Electrogram Recording and Classifying System in people with Ventricular Arrhythmia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Classifier accuracy (time frame: During intracardiac electrograms procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.