FARAPULSE is the pioneer of a new era in cardiac ablation. Our innovative technology has been used to treat patients in multiple European clinical studies.1

Atrial fibrillation (AF) is an arrhythmia affecting millions of patients and is often treated with a procedure called pulmonary vein isolation. Traditionally, extreme heating or cooling is employed to achieve the desired effect of blocking abnormal heartbeats. However, these thermal methods may carry risk to surrounding structures such as the esophagus and phrenic nerve.2

FARAPULSE Pulsed Field Ablation (PFA) is a novel, non-thermal method for cardiac ablation that is fundamentally different from traditional modalities.

FARAPULSE Pulsed Field Ablation (PFA) is a novel, non-thermal method for cardiac ablation that is fundamentally different from traditional modalities: ultra-rapid, safe and effective owing to advantages at its most fundamental level.

FARAPULSE PFA is the momentary creation of a therapeutic electric field by a purpose-built catheter inside the heart. Through a process called irreversible electroporation, cardiac tissue targeted for ablation is rendered electrically inactive while collateral tissues are spared. Unlike traditional thermal methods, which ablate indiscriminately with extreme temperatures, non-thermal FARAPULSE PFA is tissue-selective.1,2

The ADVENT Trial is a prospective randomized pivotal trial of the FARAPULSE Pulsed Field Ablation System compared with standard of care ablation in patients with paroxysmal atrial fibrillation.

The FARAPULSE procedure is similar in many ways to traditional ablation procedures for AF.  A catheter – FARAWAVE - is positioned inside the heart and energy is delivered around the pulmonary veins, an area associated with irregular heartbeats.

You may qualify for The ADVENT Trial if you meet the following criteria*:

• You are 18 to 75 years of age
• You experience AF episodes that end spontaneously within 7 days or less (with or without treatment).
• You have 2 confirmed symptomatic episodes of AF within 12 months of joining the study.
• You tried medications for AF that have not worked.

*Please note that other requirements will apply. Contact your physician to discuss The ADVENT Trial.

TRIAL LOCATIONS

For more information about The ADVENT Trial, including sites where enrollment is active, please CLICK HERE.

WHAT TO EXPECT

During The ADVENT Trial procedure, a study doctor will use either the study device or a traditional ablation device to perform an ablation procedure.

INDICATIONS & POTENTIAL RISKS

CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use in the United States.

INDICATIONS FOR USE
The FARAPULSE Pulsed Field Ablation (PFA) System is indicated for the isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation.

CONTRAINDICATIONS
There are a number of reasons why catheter ablation of the pulmonary veins should not be attempted, including using the FARAPULSE Pulsed Field Ablation System. These include previous intra-atrial septal patch, known or suspected atrial myxoma, recent heart attack or unstable angina, recent stroke, problems with anticoagulation therapy, current active infection, presence of blood clot in the heart or known problems with obtaining vascular access for heart catheterization.

POTENTIAL RISKS
The FARAPULSE Pulsed Field Ablation System is for Investigational Use Only in the United States.

Based on prior clinical research in Europe, the risk profile associated with the FARAPULSE PFA System and the ablation procedure is consistent with other similar commercially available ablation devices currently in clinical use for cardiac ablation.

While these known risks occur infrequently, they can include complications arising from placing catheters in the blood vessels and heart, creation of new heart arrhythmias, interference with the heart’s conduction system requiring a pacemaker, damage to heart structures or surrounding tissue such as nerves or the esophagus, blood clots that may cause stroke or organ damage, or scarring of the pulmonary veins. Clinical studies involving investigational procedures and/or devices may also involve risks that are currently unknown for this type of device or procedure.  

Persons interested in The ADVENT Trial in the U.S. should contact their physician to see if their specific situation is appropriate for participation. Information about participating trial sites may be found at https://clinicaltrials.gov/ct2/show/NCT04612244.

Team FARAPULSE is comprised of passionate and accomplished professionals with decades of experience in cardiac electrophysiology. Our AF experience drives a conviction that a safer, more durable and more efficient ablation modality is due.