Boston Scientific has commenced the AVANT GUARD clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System as a first-line treatment for persistent atrial fibrillation.
The first trial subject was enrolled at the Cleveland Clinic in the US.
AVANT GUARD will evaluate the safety and effectiveness of the system, marking the launch of the only trial to assess PFA as a frontline therapy in people with this type of AF.
Outcomes of ablation using the system in the trial will be compared to those reported after the use of anti-arrhythmic drug (AAD) therapy, which is usually prescribed for persistent AF.
A nonthermal treatment, the FARAPULSE PFA System works by delivering electric fields for selective ablation of heart tissue.
The randomised trial plans to enrol more than 500 persistent AF patients at up to 75 study centres worldwide.
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Participants will undergo left atrial posterior wall ablation and pulmonary vein isolation (PVI) using either FARAPULSE PFA System or AAD therapy.
The trial will evaluate the treatment outcomes including adverse events associated with the device or procedure, the rates of freedom from AF, atrial flutter, or atrial tachycardia, and AF burden in participants.
All trial participants will be fitted with the Boston Scientific LUX-Dx Insertable Cardiac Monitor, which automates the observation process by gathering and transmitting arrhythmia episode data.
It can identify cardiac arrhythmia recurrence and evaluate AF burden by providing sustained monitoring of the heart rhythm.
The company anticipates obtaining approval for the FARAPULSE PFA System from the US Food and Drug Administration in the first quarter of next year.
Boston Scientific AF Solutions chief medical officer Dr 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.”
In November this year, the company acquired Relievant Medsystems for an upfront payment of $850m.