Boston Scientific Halts Enrollment in AVANT GUARD Trial for Persistent Atrial Fibrillation Treatment
Boston Scientific Corporation (NYSE: BSX) has announced a temporary pause in enrollment for its AVANT GUARD clinical trial. The trial 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 (AFib). Persistent AFib is a condition where an irregular heart rhythm persists for more than a week.
The AVANT GUARD trial is unique in its focus on using PFA as a frontline therapy for patients with this form of AFib. The trial aims to compare the outcomes of ablation with the FARAPULSE PFA System, a nonthermal treatment that selectively ablates heart tissue, to outcomes following the use of anti-arrhythmic drug (AAD) therapy, a common treatment for persistent AFib.
Initially, the randomized AVANT GUARD trial was expected to enroll over 500 patients. However, during the third-quarter earnings investor call, Boston Scientific’s Chairman and CEO, Michael Mahoney, revealed that the company has decided to temporarily halt enrollment due to “unanticipated observations.”
The observations, which are not life-threatening, have been encountered while studying a specific patient population—drug-naive patients with persistent AFib. This population is not currently indicated for PFA treatment under existing guidelines and is not typically treated with the Farapulse system.
Despite the pause, Boston Scientific emphasizes that the observations do not affect their confidence in the overall performance of the FARAPULSE system. The company plans to resume enrollment in the near term after further investigation of the observations.
Kenneth Stein, Senior Vice President and Global Chief Medical Officer, stated, “This in no way at all affects our confidence in the overall performance of the FARAPULSE system as it’s being used today commercially or in other clinical trials.” He added, “I just want to emphasize that the patient population we’re studying in AVANT GUARD—which is drug-naive, persistent AF patients—has not previously been studied. It is a population that’s not indicated for ablation today under guidelines, and it’s not the population that’s being treated today with the Farapulse system.”
The news of the trial pause has impacted BSX stock, which was down 1.52% at $86.67 at the time of this writing. The company is expected to provide further updates on the AVANT GUARD trial as the investigation progresses.
