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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 - 12 months
Awards & highlights
AdmIRE Trial Summary
This trial is testing a new device to treat atrial fibrillation. The device is safe and effective for 12 months.
Who is the study for?
This trial is for individuals who have symptomatic paroxysmal atrial fibrillation, have had at least one documented AF episode in the past year, and failed at least one antiarrhythmic drug. It's not for those with persistent AF, previous ablations for AF, severe heart conditions like unstable angina or severe mitral regurgitation, or women who are pregnant.Check my eligibility
What is being tested?
The trial tests the VARIPULSE™ Catheter with TRUPULSE™ Generator system's safety and effectiveness in isolating pulmonary veins to treat atrial fibrillation over a period of 12 months.See study design
What are the potential side effects?
Potential side effects may include complications related to heart rhythm disturbances, issues from catheter insertion such as bleeding or infection, adverse reactions to anesthesia used during the procedure, and possible damage to surrounding structures in the heart.
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
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pulse Field Ablation
2022
N/A
~370
Find a Location
Who is running the clinical trial?
Biosense Webster, Inc.Lead Sponsor
122 Previous Clinical Trials
36,225 Total Patients Enrolled
81 Trials studying Atrial Fibrillation
28,142 Patients Enrolled for Atrial Fibrillation
Biosense Webster Inc. Clinical TrialStudy DirectorBiosense Webster, Inc.
1 Previous Clinical Trials
250 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
250 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had at least one documented episode of atrial fibrillation within the past year.You have tried at least one specific type of medication for heart rhythm problems and it didn't work.You have experienced at least two episodes of symptomatic AF in the last six months before joining the study.You have been diagnosed with atrial fibrillation that has lasted for more than 7 days.You have atrial fibrillation caused by problems with your body's electrolytes, thyroid, or other non-heart-related issues.You have had surgery or a procedure to treat atrial fibrillation.You need a treatment that involves removing tissue outside a specific area in your body.You have had heart valve surgery or a heart procedure involving a catheter.You had a heart condition called unstable angina in the last 6 months.You have a serious and long-lasting lung or breathing condition.You currently have a severe illness or infection.You have tried and it didn't work at least one specific type of medication for irregular heartbeat.You have a blockage or abnormality in your heart that makes it difficult for doctors to perform a certain type of procedure.You have a serious problem with the mitral valve in your heart.You are expected to live for less than 12 months.You have been diagnosed with symptomatic paroxysmal atrial fibrillation.You have experienced at least two symptomatic episodes of atrial fibrillation in the last six months.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 pacemaker or other implanted heart device that could be affected by the treatment's energy field.You have a medical condition that makes it difficult to access your blood vessels.You have a condition where one side of your diaphragm is partially paralyzed.Your heart's left atrium is abnormally enlarged, with a diameter of over 50 millimeters, as shown in a recent imaging test.There is a blood clot in your left atrium as seen on an imaging test within 48 hours before the procedure.Your heart's pumping function is very weak, as shown by a recent imaging test.You have been diagnosed with symptomatic paroxysmal atrial fibrillation.You have severe heart problems that are not under control.You have had a blood clot or a mini-stroke in the past year.You had a heart procedure or heart attack in the last 2 months.You have had heart bypass surgery in the last 6 months.You have had at least one documented episode of atrial fibrillation in the 12 months before joining the study.
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?
18 - 65
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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