What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation, such as radiofrequency (RF) ablation, cryoballoon ablation, and pulsed field ablation, have several known side effects. RF ablation can cause complications like cardiac tamponade, pulmonary vein stenosis, and esophageal injury. Cryoballoon ablation may lead to phrenic nerve injury, atrioesophageal fistula, and vascular complications. Pulsed field ablation, a newer technique, is generally considered to have fewer side effects, but potential risks include transient chest pain, esophageal injury, and phrenic nerve injury. All ablation procedures carry a risk of bleeding, infection, and thromboembolic events.

What prior FDA approvals exist?

The FDA has approved several treatments for Atrial Fibrillation, including catheter ablation techniques and antiarrhythmic drugs. Traditional catheter ablation methods, such as radiofrequency (RF) ablation and cryoballoon ablation, have been widely used to isolate pulmonary veins and prevent AF recurrence. Antiarrhythmic drugs like amiodarone, flecainide, and sotalol are also commonly prescribed to manage AF. The FARAPULSE Pulsed Field Ablation System represents a novel approach by using pulsed electric fields to ablate cardiac tissue, potentially offering a safer and more effective alternative to existing ablation technologies.

What other types of research exist?

Promising alternatives to the FARAPULSE Pulsed Field Ablation System for AF treatment include: 1) Cryoballoon Catheters, which use extreme cold to ablate cardiac tissue, and 2) Force-Sensing RF Catheters, which provide precise control over the ablation process. Both methods are part of the standard of care and have been compared in clinical trials for their effectiveness and safety.

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Pulsed Field Ablation System

FARAPULSE PFA vs Standard Ablation for Atrial Fibrillation (ADVENT Trial)

N/A

Waitlist Available

Led By Vivek Reddy, MD

Research Sponsored by Farapulse, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

Paroxysmal atrial fibrillation

Must not have

Diagnosed disorder of blood clotting or bleeding diathesis

AF that is persistent or requires frequent cardioversions, or is secondary to reversible/non-cardiac causes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the FARAPULSE Pulsed Field Ablation System. It aims to treat patients with irregular heartbeats that come and go, known as Paroxysmal Atrial Fibrillation (PAF). The device works by using electrical pulses to create small scars in the heart, which help prevent abnormal heart rhythms. Pulsed field ablation uses high-frequency electrical pulses to treat cardiac tissue and has shown promise in studies for its efficiency and safety.

Who is the study for?

This trial is for adults aged 18-75 with paroxysmal atrial fibrillation (PAF) who haven't responded to anti-arrhythmic drugs. Participants must be able to consent and follow study procedures. Exclusions include pregnancy, other clinical study involvement, certain heart conditions or procedures, blood disorders, uncontrolled medical issues, and severe sleep apnea.

What is being tested?

The FARAPULSE Pulsed Field Ablation System is being tested against the standard of care ablation using force-sensing RF catheters and cryoballoon catheters in patients with PAF. It's a head-to-head comparison to see which treatment works better for controlling irregular heartbeats.

What are the potential side effects?

Potential side effects may include discomfort at the site of ablation, bleeding or bruising, risk of infection from the procedure, possible damage to surrounding heart tissue or vessels leading to complications like arrhythmias or pericarditis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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It seems like the criterion is incomplete. Could you please provide more details or the full text of the criterion so that I can assist you accurately?

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I have episodes of irregular heartbeat.

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My heart rhythm medication did not work or caused side effects.

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I am between 18 and 75 years old.

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My atrial fibrillation symptoms persist despite trying medications.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed blood clotting or bleeding disorder.

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My atrial fibrillation is persistent or often needs resetting.

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I cannot receive blood thinners or undergo CT/MRI scans.

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I currently have an infection or COVID-19.

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I have sleep apnea or my doctor thinks I have less than a year to live.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs

Primary Effectiveness Endpoint

Secondary study objectives

Change in PV Cross-sectional Area

Primary Effectiveness Treatment Success Tested for Superiority

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FARAPULSE Pulsed Field Ablation SystemExperimental Treatment1 Intervention

Group II: Force Sensing Radiofrequency Ablation and Cryoballoon AblationActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FARAPULSE Pulsed Field Ablation System

2023

N/A

~920

0 / 11Eligibility criteria met

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 modifying 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, including the FARAPULSE Pulsed Field Ablation System, targets and destroys small areas of heart tissue that cause irregular electrical signals, using methods such as radiofrequency, cryotherapy, or pulsed electric fields. These treatments are crucial for AF patients as they help restore and maintain normal heart rhythm, reduce symptoms, and prevent complications such as stroke.

Contemporary Diagnosis and Management of Atrial Flutter: A Continuum of Atrial Fibrillation and Vice Versa?How to manage atrial fibrillation: an update on recent clinical trials.