What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation include pharmacologic therapies and catheter ablation. Antiarrhythmic drugs like amiodarone, flecainide, and sotalol can cause side effects such as thyroid dysfunction, liver toxicity, lung damage, and proarrhythmia. Catheter ablation, including PVI using systems like the VARIPULSE™ Catheter with TRUPULSE™ Generator, can lead to complications such as bleeding, infection, pulmonary vein stenosis, and cardiac tamponade. Both treatment types require careful monitoring to manage and mitigate these risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation (AF), particularly focusing on antiarrhythmic drugs and ablation techniques. Antiarrhythmic drugs such as amiodarone, dofetilide, and sotalol have been approved for maintaining sinus rhythm in AF patients. However, for patients with structural heart disease or heart failure, amiodarone and dofetilide are preferred. The FDA has also approved catheter ablation techniques for PVI, which is a common procedure to isolate the pulmonary veins and prevent AF. The VARIPULSE™ Catheter with TRUPULSE™ Generator represents a novel approach in this category, aiming to improve the safety and efficacy of PVI in patients with symptomatic paroxysmal AF.

What other types of research exist?

Promising novel alternatives for energy delivery in PVI for AF patients include low-energy intracardiac cardioversion using catheter-based systems and novel low-tilt biphasic waveforms delivered by radiofrequency-powered defibrillators. These methods have shown efficacy in terminating AF with potentially fewer side effects compared to conventional approaches.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 - 12 months for reporting.

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

Do I qualify?Apply below to find out

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.