Boston Scientific has announced the resumption of enrollment for its AVANT GUARD clinical trial, a study evaluating the Farapulse pulsed field ablation (PFA) system in patients with persistent atrial fibrillation. The trial had been paused in October 2024 to allow for the assessment of “unanticipated observations” made during the early stages of the study.
Kenneth Stein, Boston Scientific’s global chief medical officer, stated in an October 23rd Q3 earnings call that the observations were not life-threatening, though specific details were not disclosed at the time. Following a thorough review conducted with the data monitoring committee, the company has determined that enrollment can safely proceed.
AVANT GUARD Trial Details
The AVANT GUARD trial is designed to investigate the safety and efficacy of PFA as a first-line treatment for persistent atrial fibrillation in patients who have not yet been prescribed anti-arrhythmic drugs. This patient population, according to Stein, has not been previously studied and is not currently indicated for ablation under existing guidelines, nor are they typically treated with the Farapulse system.
The randomized trial aims to enroll over 500 patients with persistent atrial fibrillation across approximately 75 study centers worldwide. Participants will undergo either left atrial posterior wall ablation and pulmonary vein isolation (PVI) using the Farapulse system or anti-arrhythmic drug therapy.
Endpoints and Technology
The trial's primary endpoints include assessing adverse events associated with the device or procedure, the rates of freedom from atrial fibrillation, atrial flutter, or atrial tachycardia, and the overall atrial fibrillation burden in participants.
The Farapulse system offers a non-thermal approach to ablate cardiac tissue associated with atrial fibrillation, potentially minimizing damage to surrounding structures. The U.S. Food and Drug Administration (FDA) approved Farapulse in January 2024 for treating drug-refractory, recurrent, symptomatic, or paroxysmal atrial fibrillation.
Market Context
The cardiac rhythm management (CRM) devices market in the EU5 countries (the UK, Spain, Italy, France, and Germany) was valued at $2.42 billion in 2023 and is projected to reach approximately $3.68 billion by 2033. The US CRM market was worth around $4 billion in 2023 and is forecast to reach around $5.8 billion by 2033.
