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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
No Placebo-Only Group
Summary
This trial tests a new method to treat patients with irregular heartbeats who haven't improved with drugs. The treatment works by stopping abnormal signals in the heart.
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.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Freedom of arrhythmia recurrence
Incidence of early onset Primary Adverse Events
Secondary study objectives
QOL Improvement
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Atrial Fibrillation (AF) include antiarrhythmic drugs, electrical cardioversion, and catheter ablation. Antiarrhythmic drugs work by altering the electrical signals in the heart to maintain a normal rhythm.
Electrical cardioversion uses controlled electric shocks to reset the heart's rhythm. Catheter ablation, particularly pulmonary vein isolation (PVI), targets the areas of the heart where erratic electrical signals originate, using energy sources like radiofrequency or cryotherapy to create scar tissue that blocks these signals.
The VARIPULSE™ Catheter with TRUPULSE™ Generator is an example of a PVI treatment that uses energy delivery to achieve this isolation. These treatments are crucial for AF patients as they help restore and maintain normal heart rhythm, reduce symptoms, and prevent complications such as stroke.
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Who is running the clinical trial?
Biosense Webster, Inc.Lead Sponsor
126 Previous Clinical Trials
36,701 Total Patients Enrolled
85 Trials studying Atrial Fibrillation
28,618 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
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