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Pulse Field Ablation
Pulse Field Ablation for Atrial Fibrillation(AdmIRE Trial)
N/A
Waitlist Available
Research Sponsored by Biosense Webster, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation
Failed at least one Class I or Class III antiarrhythmic drug
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3 - 12 months
Awards & highlights
No Placebo-Only Group
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 Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with symptomatic paroxysmal atrial fibrillation.
Select...
You have tried at least one type of medication for heart rhythm problems, but it didn't work.
Select...
You have experienced at least two episodes of symptomatic atrial fibrillation in the past six months.
Select...
You have had a documented episode of atrial fibrillation within the past year.
AdmIRE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 - 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 - 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom of arrhythmia recurrence
Incidence of early onset Primary Adverse Events
Secondary outcome measures
QOL Improvement
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
AdmIRE Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator
Find a Location
Who is running the clinical trial?
Biosense Webster, Inc.Lead Sponsor
118 Previous Clinical Trials
36,847 Total Patients Enrolled
77 Trials studying Atrial Fibrillation
27,462 Patients Enrolled for Atrial Fibrillation
Biosense Webster Inc. Clinical TrialStudy DirectorBiosense Webster, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Atrial Fibrillation Patient Testimony for trial: Trial Name: NCT05293639 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
California
Illinois
Alabama
How old are they?
65+
18 - 65
What site did they apply to?
Memorial Health University Medical Center
Texas Cardiac Arrhythmia Research Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Currently taking medication that is not working well to control episodes of arrhythmias.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
What is the screening criteria?
PatientReceived 2+ prior treatments
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