Boston Scientific (NYSE: BSX) is resuming its “Avant Guard” study of pulse field ablation as a first-line therapy for persistent atrial fibrillation (AFib).
The device developer paused the trial last month, with CEO Mike Mahoney citing the need to “assess a few unanticipated observations.” Boston Scientific said it did not halt the trial due to any life-threatening events.
This week, Boston Scientific said it is resuming enrollment in the trial “following an assessment of observations within the trial and in conjunction with the study’s data monitoring committee.”
The Avant Guard study — formally called “A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation (PFA) versus Anti-Arrhythmic Drug (AAD) Therapy as a First-Line Treatment for Persistent Atrial Fibrillation” — seeks to demonstrate the safety and effectiveness of PFA as the initial treatment for patients with persistent AFib.
The trial is using Boston Scientific’s Farapulse PFA system, which ablates heart tissue using the Farawave PFA catheter for the isolation of pulmonary veins and the posterior wall. The study will compare those patients to other patients who get only AAD treatment.
Medical Design & Outsourcing: Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system
“The Avant Guard trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilized as an earlier treatment for persistent [AFib], which may lead to better long-term outcomes and establish the Farapulse PFA system as the preferred method for treating the disease,” Boston Scientific AF Solutions Chief Medical Officer Dr. Brad Sutton said in December 2023 when initiating the trial.
For every three study participants, two will receive PFA first and the third will get AAD (including Flecainide, Sotalol, Propafenone, Dofetilide and Dronedarone). All study participants will have LUX-Dx insertable cardiac monitors (ICMs) implanted to monitor heart activity.
The principal investigator is Dr. Oussama Wazni at The Cleveland Clinic, but the trial is currently recruiting at dozens of U.S. locations from coast to coast.
Boston Scientific wants at least 12-15% of the participants to be “persons of color” and 43-45% to be women, the company said at the trial’s webpage.
“Given the increased [AFib] risk factors and differences in management and treatment techniques among the underrepresented ethnic and racial groups, it is imperative to start improving the representation of these groups in catheter ablation trials,” the company said.
Medical Design & Outsourcing: Pulsed field ablation catheters take shape at Medtronic, Boston Scientific, Abbott and J&J’s Biosense Webster
