The clinical trial will evaluate the safety and effectiveness of the PFA system as a first-line treatment for patients with persistent AF, compared to outcomes with anti-arrhythmic drug (AAD) therapy, a common treatment for patients living with persistent AF
Boston Scientific to study FARAPULSE PFA system. (Credit: jesse orrico on Unsplash)
US-based biomedical engineering firm Boston Scientific has initiated the AVANT GUARD clinical study of its FARAPULSE pulsed field ablation (PFA) system for atrial fibrillation (AF).
The clinical trial will evaluate the safety and effectiveness of the PFA system as a first-line treatment for patients with persistent AF.
The Farapulse PFA System is designed to optimise cardiac PFA therapy, a non-thermal treatment where electric fields selectively ablate heart tissue.
It comprises a Steerable Sheath for access and navigation, a PFA Catheter to treat a range of PV anatomies, and a PFA Generator for an easy three-button click.
The study will compare the outcomes of ablation with Farapulse PFA System, to outcomes with anti-arrhythmic drug (AAD) therapy, a common treatment for patients living with persistent AF.
Boston Scientific AF Solutions chief medical officer Brad Sutton said: “With nearly 40,000 patients treated to date in clinical and commercial settings, the FARAPULSE PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build.
“The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilised as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the FARAPULSE PFA System as the preferred method for treating the disease.”
The AVANT GUARD randomised clinical trial is designed to enrol more than 500 patients diagnosed with persistent AF, at up to 75 sites worldwide.
The study participants will be randomised to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA system, or AAD treatment.
The trial will evaluate the outcomes of treatment with the FARAPULSE PFA System compared to AADs, including device- or procedure-related adverse events.
The study will also compare the rates of freedom from AF, atrial flutter, or atrial tachycardia, along with AF burden, a measurement of the amount of AF an individual experiences.
All patients in the trial will also be inserted with the Boston Scientific LUX-Dx Insertable Cardiac Monitor, which simplifies the monitoring process for patients.
LUX-Dx monitor is designed to detect the recurrence of cardiac arrhythmias, evaluate the AF burden, and automatically capture and transmit arrhythmia episode data.
Recently, the Cleveland Clinic enrolled the first patient in the AVANT GUARD trial, who is also serving as the lead investigator of the trial.