Boston Scientific has resumed enrolment for its AVANT GUARD clinical trial, after it was paused in October 2024to “assess a few unanticipated observations”.
The trial – which tests Boston Scientific’s Farapulse technology in patients with atrial fibrillation – was paused to evaluate observations made in early study stages. Boston Scientific’s global chief medical officer, Kenneth Stein, said on a 23 October Q3 earnings investor call that the observations were not life-threatening, but he could not provide more details on the ongoing study.
Following a detailed review with the data monitoring committee, the company announced that recruitment could safely proceed.
The AVANT GUARD trial investigates the safety and efficacy of pulsed field ablation (PFA) as a first-line treatment for persistent atrial fibrillation. Atrial fibrillation, a prevalent heart condition linked to severe health risks, currently has limited treatment options for patients who have not yet been prescribed anti-arrhythmic drugs.
“I just want to close by emphasising 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,” explained Stein in the Q3 earnings call.
Boston Scientific originally launched the AVANT GUARD trial last year. The randomised trial plans to enrol more than 500 persistent atrial fibrillation patients at up to 75 study centres worldwide.
In the study, participants undergo left atrial posterior wall ablation and pulmonary vein isolation (PVI) using either Farapulse or anti-arrhythmic drug therapy. The trial evaluates treatment outcomes including adverse events associated with the device or procedure, the rates of freedom from atrial fibrillation, atrial flutter, or atrial tachycardia, and atrial fibrillation burden in participants.
The system works by offering a non-thermal solution to ablate cardiac tissue associated with atrial fibrillation, potentially reducing damage to surrounding structures. The US Food and Drug Administration (FDA) approved Farapulse in January 2024 in the treatment of drug-refractory, recurrent, symptomatic, or paroxysmal atrial fibrillation.
According to reports by GlobalData, the cardiac rhythm management (CRM) devices market in the EU5 countries (the UK, Spain, Italy, France, and Germany) was worth $2.42bn in 2023 and is forecast to reach a valuation of around $3.68bn by 2033, while the US CRM market was worth around $4bn in 2023 and is forecast to reach around $5.8bn by 2033.
