Boston Scientific AVANT GUARD Study of FaraPulse Pulsed Field Ablation System Begins Enrollment

December 28, 2023—Boston Scientific Corporation announced the initiation of the AVANT GUARD clinical trial.

The study is evaluating the safety and effectiveness of the company’s FaraPulse pulsed field ablation (PFA) system as a first-line treatment for persistent atrial fibrillation (AF). The investigational device provides a nonthermal treatment in which electric fields selectively ablate heart tissue. The company anticipates FDA approval of the FaraPulse PFA system in the first quarter of 2024.

The first patient in AVANT GUARD was enrolled at the Cleveland Clinic in Cleveland, Ohio. The patient’s enrollment was overseen by the lead investigator Oussama Wazni, MD, Vice Chair of Cardiovascular Medicine and Section Head of Cardiac Electrophysiology and Pacing at Cleveland Clinic.

According to the company, outcomes of ablation with the FaraPulse PFA system will be compared to outcomes after use of anti-arrhythmic drug (AAD) therapy. AADs, which are often used to treat patients as a front-line therapy for heart rhythm maintenance, can cause adverse effects and have limited efficacy in some patients. Cardiac ablation is a potential alternative interventional strategy for patients living with persistent AF, noted Boston Scientific.

The randomized AVANT GUARD trial will enroll > 500 patients diagnosed with persistent AF at up to 75 sites globally. Patients will be randomized to undergo pulmonary vein isolation and left atrial posterior wall ablation using the FaraPulse PFA system or to receive AAD treatment and will be followed for 3 years.

The trial will evaluate the outcomes of therapy provided with the FaraPulse PFA system versus AADs, including device- or procedure-related adverse events, the rates of freedom from AF, atrial flutter, or atrial tachycardia; and AF burden, a measurement of the amount of AF an individual experiences.

All patients will also be inserted with the Boston Scientific Lux-Dx insertable cardiac monitor, which is intended to simplify the monitoring process for patients by automatically capturing and transmitting arrhythmia episode data. It is designed to detect recurrence of cardiac arrhythmias and assess AF burden by providing continuous rhythm monitoring.

The company further noted that clinical trial data presented earlier this year demonstrated that the FaraPulse PFA system is noninferior to standard-of-care therapies for the treatment of paroxysmal AF and demonstrated superior efficiency. Additional real-world data from > 17,000 patients demonstrated continued real-world safety, efficacy, and efficiency of the system.

In the third quarter of 2023, Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial (which is studying the FaraPulse PFA system for treatment of patients with drug-refractory, symptomatic, persistent AF) and also commenced enrollment in an extension arm of the study to evaluate the safety and effectiveness of adjunctive use of the FaraPoint PFA catheter for cavotricuspid isthmus ablations for the treatment of atrial flutter, stated the company.