Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF) (NCT05093868) | Clinical Trial Compass
WithdrawnNot Applicable
Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF)
Stopped: Required equipment could not be obtained
United States0Started 2022-09-02
Plain-language summary
This is a prospective, observational, single center pilot trial to find out if a new computerized technology for analysis of the electrical activity recorded during atrial fibrillation can identify the electrical source of this arrhythmia. If we are able to reliably identify the source, then in the future we may be able to use this technology to determine the optimal sites for catheter ablation of atrial fibrillation in the heart. The present study will compare the standard electrical recordings to the new computerized algorithm analysis of recordings gathered at the same time. The study will enroll 30 participants with persistent or longstanding persistent atrial fibrillation (AF) that are scheduled for elective catheter ablation of AF. The catheters that are being placed in the heart are standard Food and Drug Administration (FDA)-approved mapping catheters. The investigational computerized software that will be employed in the trial will be used after the case has done and will not directly impact any of the activities during the ablation procedure. Information learned from this trial will improve understanding of the mechanisms of atrial fibrillation and will potentially improve success rates of AF ablation for patients in the future and will be used to design a prospective trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled to undergo elective catheter ablation of AF
* History of persistent or longstanding persistent AF (see definitions below)
* Able to provide written informed consent prior to the procedure
* Age ≥18 years
Exclusion Criteria:
* Ineligible to undergo elective atrial fibrillation ablation procedure due to medical illness or poor medical condition
* Presence of a permanent endocardial pacemaker or ICD (implantable cardioverter defibrillator)
* Presence of a prosthetic mitral heart valve
* Known reversible causes of AF including clinical hyperthyroidism, pericarditis/pleuritis or other active systemic inflammatory disease including post pericardiotomy syndrome, systemic lupus erythematosus, sarcoidosis and rheumatoid arthritis
* Decompensated clinical heart failure (NYHA class 4)
* Any cerebral ischemic event (strokes or transient ischemic attacks) which occurred during the 6-month interval preceding the consent date
* History of systemic thromboembolic event defined as clinical and arteriographic evidence of thromboembolism to any distal arterial vascular bed within the past 6 months, or evidence of intracardiac thrombus at the time of the procedure
* Pregnancy (pre-procedure pregnancy serum test will be performed in all premenopausal women)
* Unable to provide own informed consent due to cognitive impairment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with correlation in detection of sources of atrial fibrillation between the electrographic flow (EGF) mapping multielectrode basket catheter and the high-density (HD) regional mapping catheter.
Timeframe: During elective catheter ablation procedure, an average duration of 3 to 6 hours