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Pulse Field Ablation for Atrial Fibrillation(AdmIRE Trial)
AdmIRE Trial Summary
This trial is testing a new device to treat atrial fibrillation. The device is safe and effective for 12 months.
AdmIRE Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
AdmIRE Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
AdmIRE Trial Design
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Who is running the clinical trial?
- You have been diagnosed with symptomatic paroxysmal atrial fibrillation.You have a history of blood clots, bleeding problems, or cannot take certain blood-thinning medications.You have been diagnosed with a condition called pulmonary vein stenosis in the past.You have a condition that makes it difficult to access your blood vessels.You are not expected to live for more than a year.You have tried at least one specific type of medication for heart rhythm problems and it didn't work.You have a blood clot in your left atrium that was seen on a scan within 48 hours before the procedure.You have a serious problem with the mitral valve in your heart.You have tried at least one type of medication for heart rhythm problems, but it didn't work.You have been diagnosed with symptomatic paroxysmal atrial fibrillation.You have had a blood clot or stroke in the past year.You have had heart valve surgery or a heart procedure involving a catheter.Your heart's left atrium is very enlarged, with a diameter over 50mm, as seen in a recent imaging test.You have been diagnosed with symptomatic paroxysmal atrial fibrillation.You have been diagnosed with persistent atrial fibrillation for more than 7 days.You have atrial fibrillation caused by problems with your body's electrolyte balance, thyroid issues, or other non-heart related reasons.You have had surgery or a procedure to treat atrial fibrillation in the past.You need a procedure to remove tissue outside a specific area in the body.A test within the past 6 months showed that your heart is not pumping well (LVEF <40%).You have severe heart problems that are not well controlled.You have had a heart procedure or heart attack within the last 2 months.You had heart bypass surgery in the last 6 months.You have had unstable angina in the past 6 months.You have a serious long-term lung or breathing problem with severe symptoms.You already have paralysis in one side of your diaphragm.You have a heart condition that would make it difficult to use a catheter during the study.You have a pacemaker, Implantable Cardioverter-Defibrillator (ICD), or other metal heart device that could be affected by the treatment's energy field.You have had at least one episode of atrial fibrillation (AF) recorded on an electrocardiogram in the past year.You have experienced at least two episodes of symptomatic atrial fibrillation in the past six months.You have had a documented episode of atrial fibrillation within the past year.You have had at least one recorded episode of atrial fibrillation in the past year.You have not responded well to at least one type of antiarrhythmic medication.You have experienced at least two symptomatic AF episodes in the last six months before joining the study.You have experienced at least two noticeable episodes of atrial fibrillation in the last six months.
- Group 1: Treatment Group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there a considerable number of sites in the US running this clinical research?
"This trial is recruiting patients from 34 different sites, such as the Albert Einstein College of Medicine in Bronx, Piedmont Healthcare in Atlanta, and Virginia Commonwealth University in Richmond."
Is the minimum age limit for this trial set at twenty years or younger?
"This medical trial has a lower age limit of 18 years old, and an upper bound of 75."
What criteria must a participant meet to be eligible for this trial?
"This clinical study seeks 362 participants who are 18-75 and suffering from symptomatic paroxysmal atrial fibrillation. Eligibility criteria include two episodes of AF in the last six months, one episode documented on ECG within 12 months, and failure to respond to Class I or III antiarrhythmic drugs."
Does this trial still have vacancies for prospective participants?
"Based on information provided by clinicaltrials.gov, this trial is not currently recruiting participants and has been inactive since November 28th 2022. Despite this fact, there remain 476 other studies actively searching for eligible candidates."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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